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Contents 1. Introduction and Contacts..….……….…….P.1
2. Qualifications Pack……….………………........P.2
3. Glossary of Key Terms ….……………..........P.4
4. NOS Units………………………..….……..………..P.6
5. Annexure: Nomenclature for QP and OS..P.45
6. Assessment Criteria……………………………….P.47
technology consul t ing
OS describe what
individuals need to do, know and understand in order to carry out a particular job role or function
OS are
performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding
New Delhi E-mail:
Qualifications Pack-Scientist Clinical Research and
Development
SECTOR: LIFE SCIENCES
SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL
OCCUPATION: RESEARCH & DEVELOPMENT
REFERENCE ID: LFS/Q0507
ALIGNED TO: NCO-2004/NIL
Scientist Clinical Research and Developments is responsible for planning and directing studies to investigate about the disease, preventive methods, and treatments for the same.
Brief Job Description: Scientist Clinical Research and Development plans and directs studies to investigate human or animal disease, preventive methods and treatment for diseases while carrying out functions such as investigation, support in clinical trials, analysis of clinical data, supervision etc.
Personal Attributes: The individual should have good knowledge of standard documentation procedures, rules, regulations and statutory requirements in carrying out research and development. The individual must demonstrate attention to detail and proactive behaviour. The individual should be well versed with the drugs used in the investigation studies.
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Introduction
QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY
Qualifications Pack For Scientist Clinical Research and Development
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Qualifications Pack Code
LFS/Q0507
Job Role Scientist Clinical Research and Development
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Sub-sector
Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
NSQC Clearance on 20/07/2015
Job Role Scientist Clinical Research and Development
Role Description
The Scientist Clinical Research and Development plans and directs studies to investigate disease, preventive methods and treatment for diseases while carrying out functions such as investigation, clinical trials, analysis of clinical data, supervision etc.
NSQF level Minimum Educational Qualifications Maximum Educational Qualifications
6
Master’s degree in pharmaceutical, biotechnology, nursing or life sciences/ M. Pharma. /M.Sc. in the above disciplines
Doctorate in pharmaceutical, biotechnology, nursing or life sciences/ MBBS/ MD (Pharmacology)
Training (Suggested but not mandatory)
On the job training
Minimum Job Entry Age 27 Years
Experience
Minimum of 5 years of experience in clinical drug development or in the pharmaceutical/ life sciences industry
Applicable National Occupational Standards (NOS)
Compulsory: 1. LFS/N0522: Carry out investigation
2. LFS/N0523: Supervise and guide laboratory personnel
3. LFS/N0524: Conduct analysis and interpretation of data
Job
Det
ails
Qualifications Pack For Scientist Clinical Research and Development
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Qualifications Pack For Scientist Clinical Research and Development
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4. LFS/N0102: Carry out reporting and documentation
5. LFS/N0101: Maintain a healthy, safe and secure working
environment in the life sciences sector
6. LFS/N0525: Assist in research activities
7. LFS/N0526: Work with cross functional teams for carrying
out research activities
8. LFS/N0527: Conduct clinical trials
Optional:
N.A.
Performance Criteria As described in the relevant NOS units
Qualifications Pack For Scientist Clinical Research and Development
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Keywords /Terms Description
Core Skills/Generic Skills
Core Skills or Generic Skills are a group of skills that are key to learning and working in today's world. These skills are typically needed in any work environment. In the context of the NOS, these include communication related skills that are applicable to most job roles.
Description Description gives a short summary of the unit content. This would be helpful to anyone searching on a database to verify that this is the appropriate NOS they are looking for.
Function
Function is an activity necessary for achieving the key purpose of the sector, occupation, or area of work, which can be carried out by a person or a group of persons. Functions are identified through functional analysis and form the basis of NOS.
Job role
Job role defines a unique set of functions that together form a unique employment opportunity in an organisation.
Knowledge and Understanding
Knowledge and Understanding are statements, which together specify the technical, generic, professional and organisational specific knowledge that an individual needs in order to perform to the required standard.
National Occupational Standards (NOS)
NOS are Occupational Standards, which apply, uniquely in the Indian context.
Occupation
Occupation is a set of job roles, which perform similar/related set of functions in an industry.
Organisational Context
Organisational Context includes the way the organisation is structured and how it operates, including the extent of operative knowledge managers have of their relevant areas of responsibility.
Performance Criteria
Performance Criteria are statements that together specify the standard of performance required when carrying out a task.
Qualifications Pack(QP)
Qualifications Pack comprises the set of NOS, together with the educational, training and other criteria required to perform a job role. A Qualifications Pack is assigned a unique qualification pack code.
Qualifications Pack Code
Qualifications Pack Code is a unique reference code that identifies a qualifications pack.
Scope
Scope is the set of statements specifying the range of variables that an individual may have to deal with in carrying out the function which have a critical impact on the quality of performance required.
Sector Sector is a conglomeration of different business operations having similar businesses and interests. It may also be defined as a distinct subset of the economy whose components share similar characteristics and interests.
Def
init
ion
s
Qualifications Pack For Scientist Clinical Research and Development
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Sub-Sector Sub-sector is derived from a further breakdown based on the characteristics and interests of its components.
Sub-functions
Sub-functions are sub-activities essential to fulfil the achieving the objectives of the function.
Technical Knowledge
Technical Knowledge is the specific knowledge needed to accomplish specific designated responsibilities.
Unit Code
Unit Code is a unique identifier for an NOS unit, which can be denoted with an ‘N’.
Unit Title
Unit Title gives a clear overall statement about what the incumbent should be able to do.
Vertical
Vertical may exist within a sub-sector representing different domain areas or the client industries served by the industry.
Keywords /Terms Description
NOS National Occupational Standard(s)
NSQF National Skill Qualifications Framework
NCO-2004 National Classification of Occupations-2004
OS Occupational Standard(s)
QP Qualifications Pack Acr
on
yms
LFS/N0522 : Carry out investigation
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Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to carry out investigational studies.
National Occupational
Standards
LFS/N0522 : Carry out investigation
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Unit Code LFS/N0522
Unit Title (Task)
Carry out investigation
Description This NOS is about a Scientist Clinical Research and Development performing the required activities to effectively carry out investigational studies.
Scope
The unit/ task covers the following: 1. Examining organs, tissues, fluids or cells 2. Performing moderate and high complexity laboratory tests
Performance Criteria (PC) w.r.t. the Scope
Element
Performance Criteria
Examining organs, tissues, fluids or cells.
To be competent, the user/individual on the job must be able to: PC1. examine and analyze at microscopic, chemical and molecular level the body
fluids and cells to look for bacteria, parasites, and other microorganisms. PC2. inoculate cultures carefully needed to identify bacteria. PC3. analyze the chemical reactions to determine concentrations of compounds
such as blood glucose and cholesterol levels. PC4. identify blood groups and cross matching blood for transfusions. PC5. monitoring the effects of medication by testing how a patient is responding to
treatment. PC6. perform tests in all sections of the laboratory including
haematology,bacteriology,chemistry,urinalysis,serology,immunohematology,for
ensicpathology,immunology,and toxicology.
Performing moderate
and high complexity
laboratory tests
PC7. ensure the conditions required for the maintenance of sample. PC8. perform some non-automated and specialized laboratory procedures. PC9. follow set procedures to deal with contingencies arising during
i nvestigations. PC10. determine the presence of normal or abnormal components by
physical examination, laboratory testing and through diagnostic
imaging techniques including radiography and ultrasound.
PC11. testing of samples using molecular diagnostics and highly involved microbiological and cross-matching blood tests.
PC12. identify factors which may prevent or alter specific disease. PC13. identify types and uses of vaccines in the prevention of infection. PC14. develop and implement new tests and methodologies as required.
A. Organisational Context (Knowledge of the Company/ Organisation and
The user/individual on the job needs to know and understand:
KA1. chemicals used in the industry and their function.
KA2. personal protection (which protective equipment to be used and how).
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LFS/N0522 : Carry out investigation
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its processes) KA3. the levels of hygiene required by workplace and importance of maintaining the same.
KA4. availability and use of monitoring and measuring devices. KA5. implications of inaccurate measuring and testing. KA6. implications (impact on internal/external customers)of defective
products, materials or components.
B. Technical Knowledge
The user/individual on the job needs to know and understand: KB1. the basic structure and functions of the integumentary,
skeletal,muscular,nervous,endocrine,cardiovascular,lymphatic,respiratory,digestive,urinary,and reproductive systems.
KB2. tests to be conducted on samples and related handling and preparation requirements and responsibilities.
KB3. the cells, their development, identification and functions and the microscopic examination of blood films.
KB4. characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur.
KB5. the basic concepts of transfusion science, including the application of genetics and immunology to transfusion practice.
KB6. major blood group systems, antibody detection and identification procedures.
KB7. role of different materials, chemicals and equipment. KB8. testing equipment and related test methods and purpose of tests. KB9. calibration procedure for test equipment. KB10. standard method of drawing samples and preparing them for testing. KB11. methods/techniques used for labeling samples. KB12. procedure to be followed in case the sample is unfit for testing. KB13. national/international standard test methods for different compounds. KB14. the methods that can be used for controlling test variables. KB15. factors that adversely affect integrity of the sample. KB16. knowledge of high-resolution functional magnetic resonance imaging MRI
equipment; Medical magnetic resonance imaging MRI equipment.
KB17. procedures for chemical analysis of body fluids as per organizational protocol.
KB18. procedures for the reporting of abnormal constituents in body fluids to the
right concerned person as per the organizational policy
Skills (S)
A. Core Skills/ Generic Skills
Writing skills
The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using
written/typed report or computer based record/electronic mail write detailed reports for investigation.
SA2. maintain proper and concise records as per given format.
Reading skills
LFS/N0522 : Carry out investigation
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The user/individual on the job needs to know and understand how to: SA3. read and understand manuals, SOPs, health and safety instructions, memos,
reports, job cards etc. SA4. read images, graphs, diagrams. SA5. understand the various coding systems as per company norms.
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA6. communicate confidential and sensitive information discretely to authorized
person as per SOP
SA7. listen effectively
B. Professional Skills
Decision Making
The user/individual on the job needs to know and understand how to: SB1. evaluate multiple options on defined, objective parameters SB2. appropriately use the escalation matrix for complex decisions
Critical Thinking
The user/individual on the job needs to know and understand how to: SB3. apply balanced judgement to different situations SB1. apply, analyse and evaluation information to define action steps
Plan & Organize
The user/individual on the job needs to know and understand how to: SB4. plan and organize investigation as per deadlines
Analytical Skills
The user/individual on the job needs to know and understand how to: SB5. identify, define and resolve problems using a structured methodology SB6. suggest improvements(if any) in process based on experience
Problem Solving
NA
Customer Centricity
NA
LFS/N0522 : Carry out investigation
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NOS Version Control
NOS Code LFS/N0522
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0526 : Work with cross-functional teams for carrying out research activities
12 | P a g e
Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to effectively work with cross functional teams.
National Occupational
Standards
LFS/N0526 : Work with cross-functional teams for carrying out research activities
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Unit Code LFS/N0526
Unit Title (Task)
Work with cross functional teams for carrying out research activities
Description This NOS unit is about a Scientist Clinical Research and Development working with cross functional teams.
Scope
The unit/ task covers the following: 1. Working effectively with others.
Performance Criteria (PC) wrt the Scope
Element
Performance Criteria
Working effectively with others
To be competent, you must be able to:
PC1. working effectively with other people who can be part of the immediate team, organization or external to the team or organization to meet requirements.
PC2. sharing information with others to enable efficient delivery of work. PC3. communicating with other team members and people internal or external to
the organization. PC4. provide and receive support and feedback from others in the team. PC5. work with biostatistician, scientists in the other field and from different regions
collaboratively to develop study design and pursue research further.
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
You need to know and understand: KA1. strong understanding of quality systems and procedures. KA2. risk and impact of not following defined procedures/work instructions . KA3. types of documentation in organization, importance of maintaining the same
and different methods of recording information . KA4. impact of various practices on cost, quality, productivity, delivery and safety . KA5. procedures for reporting any unresolved issues and hazards. KA6. reporting incidents where standard operating procedures are not followed . KA7. the knowledge about the appropriate authority for reporting any imbalances.
B Technical Knowledge
You need to know and understand: KB1. knowledge on different standard reference material . KB2. use of Computer/application software .
Skills (S)
Writing skills
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LFS/N0526 : Work with cross-functional teams for carrying out research activities
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A. Core Skills/ Generic Skills
The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using
written/typed report SA2. communicate with supervisor and team members data/ information/ support/
advice needed
Reading skills
The user/individual on the job needs to know and understand how to: SA3. read and interpret written data/information/ communication carefully
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA4. be clear and precise in communication SA5. listen effectively SA6. maintain confidentiality of information and data
B. Professional Skills
Critical Thinking
The user/individual on the job needs to know and understand how to:
SB1. apply balanced judgement to different situations SB2. provide sound, constructive, objective opinion
Plan and Organize
The user/individual on the job needs to know and understand how to:
SB3. work effectively with cross-functional team members across multiple functions, locations and hierarchy level
SB4. establish rapport and effective working relationships with business partners, department leadership and peers
Decision Making
The user/individual on the job needs to know and understand how to: SB5. act objectively when faced with difficult/stressful or emotional situations SB6. appropriately use the escalation matrix for complex team decisions SB7. collaborate with the team for taking decisions
Problem Solving
The user/individual on the job needs to know and understand how to:
SB8. apply problem solving approaches to different situations SB9. solve conflicts within the team
Analytical Thinking
NA
LFS/N0526 : Work with cross-functional teams for carrying out research activities
15 | P a g e
Customer Centricity
NA
NOS Version Control
NOS Code LFS/N0526
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0527 : Conduct clinical trials
16 | P a g e
Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to effectively conduct clinical trials.
National Occupational
Standards
LFS/N0527 : Conduct clinical trials
17 | P a g e
Unit Code LFS/N0527
Unit Title (Task)
Conduct clinical trials
Description This NOS unit is about a Scientist Clinical Research and Development to conduct clinical trials.
Scope
The unit/task covers the following: 1. Conduct pre-clinical studies. 2. Performing clinical trials.
Performance Criteria (PC) wrt the Scope
Element
Performance Criteria
Conduct pre-clinical studies
To be competent, you must be able to: PC1. conduct in vitro i.e. test tube or cell culture experiments. PC2. conduct in vivo i.e. animal experiments. PC3. use wide-ranging doses of the study drug to obtain preliminary efficacy,
toxicity and pharmacokinetic information. PC4. assess whether a drug candidate has scientific merit for further development as an
investigational new drug.
Performing Clinical Trials
PC5. establish the dose range tolerated by volunteers for single and for multiple doses
PC6. conduct all the phases of clinical trial. PC7. gather preliminary data on the pharmacodynamics (what the drug does to the
body)and pharmacokinetics(what the body does to the drugs). PC8. assessthesafety(pharmacovigilance),tolerability,pharmacokinetics,andpharmac
odynamicsofadrug. PC9. determine a safe dose range. PC10. identify and monitor side-effects of the drug. PC11. provide regulatory submission i.e. comprehensive description of the methods
and results of human and animal studies, manufacturing procedures, formulation details, and shelf life for review to the appropriate regulatory authorities.
PC12. detect any rare or long-term adverse effects over a much larger patient population
and longer time period.
Knowledge and Understanding (K)
B. Organisational Context (Knowledge of the Company/ Organisation and its processes)
You need to know and understand: KA1. the principles and processes to provide patient care, including patient need
assessment, meeting quality standards for services, and evaluation of customer satisfaction.
KA2. material disposal procedure, importance of appropriate disposal of material and implications of not following the material disposal procedure.
KA3. risk and impact of not following defined procedures/work instructions. KA4. reporting incidents where standard operating procedures are not followed. KA5. the importance of complete and accurate documentation. KA6. the importance of quality control procedures.
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LFS/N0527 : Conduct clinical trials
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KA7. measures, steps and possible solutions that have been taken/identified to address the previous problems.
KA8. the correct method for carrying out corrective actions outlined for each problem.
KA9. usage of LIMS(Laboratory information management system).
B Technical Knowledge
You need to know and understand: KB1. the basic structure and functions of the integumentary, skeletal, muscular,
nervous,endocrine,cardiovascular,lymphatic,respiratory,digestive,urinary,and reproductive systems.
KB2. tests to be conducted on samples and related handling and preparation requirements and responsibilities.
KB3. the cells, their development, identification and functions and the microscopic examination of blood films.
KB4. knowledge on different standard reference material. KB5. testing equipment and related test methods and purpose of tests. KB6. calibration procedure for test equipment. KB7. sampling techniques relevant to samples collected, such as sterilization
methods and procedures.
KB8. procedures and responsibility for reporting and recording sampling information, such as legislative requirements.
KB9. the process of undertaking sterilization of the unit. KB10. the chemical composition, structure, and properties of substances and of the
chemical processes and transformations that they undergo including the use
ofchemicalsandtheirinteractions,dangersigns,productiontechniques,and disposal
methods.
KB11. evaluate the likely success of an idea in relation to the demands of the situation.
KB12. conduct all the phases of clinical trial.
KB13. use of wide range of drugs on the subject.
Skills (S)
A. Core Skills/ Generic Skills
Writing Skills
The user/individual on the job needs to know and understand how to:
SA1. record and communicate details of work done to appropriate people using written/typed report or computer based record/electronic mail write detailed reports for investigation.
SA2. maintain proper and concise records as per given format
SA3. maintain confidentiality of information and data
Reading skills
The user/individual on the job needs to know and understand how to: SA4. read and understand manuals, SOPs, health and safety instructions, memos,
reports, job cards etc.
LFS/N0527 : Conduct clinical trials
19 | P a g e
SA5. read images, graphs, diagrams. SA6. understand the various coding systems as per company norms.
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA7. disclose information only to those who have the right and need to know it. SA8. communicate confidential and sensitive information discretely to authorized
person as per SOP.
B. Professional Skills
Analytical Thinking
The user/individual on the job needs to know and understand how to: SB1. pay attention to detail when handling equipment/apparatus SB2. suggest improvements(if any) in protocol execution SB3. spot process disruptions and delays in protocol execution and report and
communicate with solutions
Critical Thinking
The user/individual on the job needs to know and understand how to: SB7. apply balanced judgement to different situations SB4. apply, analyse and evaluation information to define protocol execution action steps
Problem Solving
The user/individual on the job needs to know and understand how to: SB5. explore new ways of doing things SB6. think through problems, evaluate the possible solutions and suggest an optimum
solution, including identify immediate or temporary solutions to resolve delays
Decision Making
The user/individual on the job needs to know and understand how to: SB8. evaluate multiple options on defined, objective parameters SB9. collaborate with the team for taking decisions
Plan & Organize
The user/individual on the job needs to know and understand how to: SB10. plan and organize assigned work in order to achieve specified targets and deadlines
of the clinical trials SB11. effectively interact with the various stakeholders in the clinical trial process
Customer Centricity
NA
LFS/N0527 : Conduct clinical trials
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NOS Version Control
NOS Code LFS/N0527
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0524 : Conduct analysis and interpretation of data
21 | P a g e
Overview
This Occupational Standard describes the knowledge, understanding and skills required of a Scientist Clinical Research and Development to conduct analysis and interpretation of data.
National Occupational
Standards
LFS/N0524 : Conduct analysis and interpretation of data
22 | P a g e
Unit Code LFS/N0524
Unit Title (Task)
Conduct analysis and interpretation of data
Description This NOS unit is about conducting analysis and interpretation of data by the Scientist Clinical Research and Development.
Scope
This Unit/task covers the following: 1. Different methodology to analyse data by applying the principles and
processes of statistical analysis.
2. Report writing based on the analysis.
Performance Criteria (PC) w.r.t. the Scope
Element
Performance Criteria
Different methodology to analyse data by applying the principles and processes of statistical analysis
To be competent, the user/individual on the job must be able to: PC1. identify the appropriate analytical process to be used to analyze the data and
consult with relevant people, gathering all the data relevant to the analysis PC2. prepare the statistical analysis plan, which describes the proposed analysis in
detail. PC3. ensure the presence of the data and information required to perform the
analysis. PC4. collate all the data required for the analysis. PC5. review the data and information to select the methodology required to analyze
the data. PC6. performing quality checks on the data accordance with organizational
policies and procedures. PC7. compile the results of the analyze and check for any variances in the data. PC8. report any variances to the appropriate people and deal with them in
accordance with organizational policies and procedures. PC9. carryout statistical and graphical methods to present the results of the analysis.
Report writing based on the analysis.
PC10. carryout the report writing within the agreed timeline. PC11. issue the report, requesting feedback from the agreed people reviewing the report. PC12. ensure that amendments are made in line with organizational policies and
procedures. PC13. issue the final report to the relevant personnel.
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. escalation matrix for reporting identified issues, hazards and breakage. KA2. types of documentation in organization, importance of maintaining the same
and different methods of recording information. KA3. the reason and impact of the occurrence of problems. KA4. measures, steps and possible solutions that have been taken/identified to
address the previous problems. KA5. usage of LMIS(Laboratory information management system).
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LFS/N0524 : Conduct analysis and interpretation of data
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B. Technical Knowledge
The user/individual on the job needs to know and understand: KB1. knowledge on different standard reference material.
KB2. statistical analysis of test data. KB3. use of Computer/application software. KB4. knowledge about SAS program. KB5. knowledge of process information by compiling, coding, categorizing, calculating,
tabulating, auditing or verifying data.
Skills (S)
A. Core Skills/ Generic Skills
Writing skills
The user/ individual on the job needs to know and understand how to: SA1. record details of work done to using written/typed report or computer based
record/electronic mail SA2. maintain proper and concise records as per given format SA3. prepare analysis and trend observation reports
Reading skills
The user/individual on the job needs to know and understand how to: SA4. read data/ information /notes/comments gathered from stakeholders SA5. communicate confidential and sensitive information discretely to authorized person SA6. read information on databases
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA7. communicate effectively with the team members and supervisors SA8. communicate confidential and sensitive information discretely to authorized person
as per SOP
B. Professional Skills
Analytical thinking
The user/individual on the job needs to know and understand how to: SB1. suggest improvements(if any) in process/formats for reports/documentation based
on experience and observation SB2. analyse gathered information and data for trends identification SB3. apply statistical and computer skills Critical Thinking
The user/individual on the job needs to know and understand how to: SB4. apply balanced judgement for interpreting data analysis results SB5. provide sound, constructive, objective opinion
Plan and Organise
The user/individual on the job needs to know and understand how to:
SB6. effectively plan and allocate work amongst team members SB7. take responsibility for completing one’s own work assignment
LFS/N0524 : Conduct analysis and interpretation of data
24 | P a g e
SB8. plan and prioritize work basis criticality and urgency
Problem Solving
NA
Decision Making
NA
Customer Centricity
NA
LFS/N0524 : Conduct analysis and interpretation of data
25 | P a g e
NOS Version Control
NOS Code LFS/N0524
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0102 : Carry out reporting and documentation
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Overview
This Occupational Standard describes the knowledge, understanding and skills required of a Scientist CRD for reporting and recording of data/problem/incidents etc. and to maintain information security.
National Occupational
Standards
LFS/N0102 : Carry out reporting and documentation
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Unit Code LFS/N0102
Unit Title (Task)
Carry out reporting and documentation
Description This NOS is about a Scientist CRD for reporting ,recording and documentation of data/problem/incidents etc. and to maintain information security
Scope
The unit covers the following:
1. Reporting of data/problem/incidents etc.
2. Recording and documentation 3. Information security
Performance Criteria (PC) w.r.t. the Scope
Element
Performance Criteria
Reporting of data/problem/incidents etc.
To be competent, the user/individual on the job must be able to: PC1. report data/problems/incidents as applicable in a timely manner
PC2. report to the appropriate authority as laid down by the company
PC3. follow reporting procedures as prescribed by the company
Recording and Documentation
PC4. identify documentation to be completed relating to one’s role
PC5. record details accurately in an appropriate format
PC6. complete all documentation within stipulated time according to company
procedure
PC7. ensure that the final document meets regulatory and compliance
requirements
PC8. make sure documents are available to all appropriate authorities to inspect
Information Security PC9. respond to requests for information in an appropriate manner whilst
following organizational procedures
PC10. inform the appropriate authority of requests for information received
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. types of documentation in organization, importance of maintaining the same
and different methods of recording information
KA2. reporting incidents where standard operating procedures are not followed
KA3. the importance of complete and accurate documentation
KA4. knowledge of production workflow sequences and materials demand
KA5. escalation matrix for reporting identified issues, hazards and breakage
B. Technical Knowledge
The user/individual on the job needs to know and understand:
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KB1. obtain and interpret records, charts, specifications, equipment manuals, history/technical support reports and other documents
Skills (S)
A. Core Skills/ Generic Skills
Writing skills
The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using
written/typed report SA2. maintain proper records as per given format
Reading skills
The user/individual on the job needs to know and understand how to: SA3. read and understand manuals, SOPs, health and safety instructions, memos,
reports, job cards etc. SA4. ability to read and interpret images, graphs, diagrams for typical product
specifications, job sheets, procedures, basic machine control panels, material labels and safety information as provided
SA5. understand the various coding systems as per company norms
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA6. disclose information only to those who have the right and need to know it. SA7. communicate confidential and sensitive information discretely to
authorized person as per SOP SA8. communicate with people in a form and manner and using language that is
open and respectful
B. Professional Skills
Analytical Thinking
The user/individual on the job needs to know and understand how to: SB1. attention to detail SB2. use of automated report writing and documentation technologies
Critical Thinking
The user/individual on the job needs to know and understand how to: SB3. suggest improvements(if any) in process based on experience
Plan and Organise
The user/individual on the job needs to know and understand how to:
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SB4. capacity and skill to learn from experience in a range of settings and scenarios and the capacity to reflect on and analyze one’s learning.
Problem Solving
The user/individual on the job needs to know and understand how to: SB5. act objectively , rather than impulsively or emotionally when faced with
difficult/stressful or emotional situations
Decision Making
NA
Customer Centricity
NA
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NOS Version Control
NOS Code LFS/N0102
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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National Occupational
Standards
Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist CRD to ensure healthy, safe and secure working environment in the life sciences facility.
LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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Unit Code LFS/N0101
Unit Title (Task)
Maintain a healthy, safe and secure working environment
Description This NOS is about a Scientist CRD monitoring the working environment and making sure that it meets the requirements for health, safety and security in the pharmaceutical/contract research/biopharmaceutical facility/manufacturing/testing/analysis/research laboratory.
Scope
The unit/task covers the following: Ensuring healthy, safe and secure working environment:
Self-monitor and adhere to safety principles and standards and report any identified breaches in health, safety, and security policies and procedures to the designated person
Identify and recommend opportunities for improving health, safety, and security to the designated person
Managing emergency procedures:
Illness
Accidents
Fires
Other reasons to evacuate the premises
Breaches of security
Performance Criteria (PC) w.r.t. the Scope
Element
Performance Criteria
Ensuring healthy, safe and secure working
environment
To be competent, the user/individual on the job must be able to carry out: Ensuring healthy, safe and secure working environment: PC1. observe and comply with your company’s current health, safety and security
policies and procedures
PC2. while carrying out work, use appropriate safety gears like head gear, masks,
gloves and other accessories as mentioned in the guidelines
PC3. report any identified breaches in health, safety, and security policies and
procedures to the designated person
PC4. responsible for maintaining discipline at the shop-floor area
PC5. identify and correct any hazards that you can deal with safely, competently and
within the limits of your authority
PC6. adhere and comply to storage and handling guidelines for hazardous material
PC7. identify and recommend opportunities for improving health, safety, and
security to the designated person
PC8. complete any health, safety and security records legibly and accurately
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Managing
emergency
procedures
PC9. report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected PC10. follow your company’s emergency procedures promptly, calmly, and efficiently
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. legislative requirements and company’s procedures for health, safety and
security and your role and responsibilities in relation to this
KA2. what is meant by a hazard, including the different types of health and safety
hazards that can be found in the workplace
KA3. how and when to report hazards
KA4. limits of your responsibility for dealing with hazards
KA5. your organization’s emergency procedures for different emergency situations
and the importance of following these
KA6. the importance of maintaining high standards of health, safety and security
KA7. implications that any non-compliance with health, safety and security
may have on individuals and the organization
KA8. health hazards and its implications if any in the production process
B. Technical Knowledge
The user/individual on the job needs to know and understand: KB1. different types of breaches in health, safety and security and how and when to
report these
KB2. evacuation procedures for workers and visitors
KB3. how to summon medical assistance and the emergency services, where
necessary
KB4. how to use the health, safety and accident reporting procedures and the
importance of these
KB5. different types of occupational health hazards
KB6. knowledge of chemical substances, their characteristics and required
precaution and safety measures
Skills (S)
A. Core Skills/ Generic Skills
Writing Skills
The user/ individual on the job needs to know and understand how to: SA1. report/observation writing skills
Reading Skills
The user/individual on the job needs to know and understand how to: SA2. read notes/comments from the supervisor SA3. read job sheets and interpret technical details mentioned in the jobsheet
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Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA4. interact with team members to work efficiently
B. Professional Skills
Decision Making
The user/individual on the job needs to know and understand how to: SB1. spot and communicate potential areas of disruptions to work process and
report the same SB2. when to report to supervisor and when to deal with a colleague individually,
depending on the type of concern
Problem Solving
The user/individual on the job needs to know and understand how to: SB3. improve work processes by interacting with others and adopting best practices
Critical Thinking
The user/individual on the job needs to know and understand how to: SB4. spot process disruptions and delays and report and communicate with solutions
Analytical Thinking
NA
Plan and Organize
NA
Customer Centricity
NA
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NOS Version Control
NOS Code LFS/N0101
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0523 : Supervise and guide laboratory personnel
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Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to supervise and guide laboratory personnel.
National Occupational
Standards
LFS/N0523 : Supervise and guide laboratory personnel
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Unit Code LFS/N0523
Unit Title (Task)
Supervise and guide laboratory personnel
Description This NOS unit is about a Scientist Clinical Research and Development to supervise and guide laboratory personnel.
Scope
The unit/ task covers the following:
Managing a laboratory.
Supervising, training and/or directing other laboratory personnel.
Performance Criteria (PC) wrt the Scope
Element
Performance Criteria
Managing a laboratory
To be competent, you must be able to: PC1. inspect equipment, structures, or materials to identify the cause of errors or
other problems or defects. PC2. generate or use different sets of rules for combining or grouping things in
different ways. PC3. ensure the relevant policies and procedures followed in the organization.
PC4. report any variances to the appropriate people and deal with them in
accordance with organizational policies and procedures.
Supervising, training and/or directing other laboratory personnel.
PC5. supervising, training and/ or directing laboratory technicians, assistants, or
other medical laboratory workers engaged in laboratory testing.
PC6. deal with people at junior levels to effectively direct their work towards optimum output.
PC7. analyse the training needs of the laboratory personnel’s. PC8. select and prepare training and instruction resources to deliver the activities. PC9. training the laboratory personnel’s on the Good Laboratory Practice;GLP. PC10. guiding the laboratory personnel’s on the new automated laboratory
techniques. PC11. monitor and refine training activities to improve the trainee's attainment of
required scientific or technical skills. PC12. supervising the team of laboratory personnel’s in carrying out advanced
testing and in dealing with highly automated equipment. PC13. communicating with other team members and people internal or external to
the organization.
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
You need to know and understand: KA1. different quality management systems (ISO-9000,TS16949,ISO-14001,OHSAS-
18000),good laboratory and manufacturing practices.
KA2. risk and impact of not following defined procedures/work instructions.
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KA3. measures, steps and possible solutions that have been taken/identified to address the previous problems.
KA4. the correct method for carrying out corrective actions outlined for each problem.
B Technical Knowledge
You need to know and understand: KB1. role of different materials, chemicals and equipment.
KB2. knowledge of hazardous material and dealing with disasters, if any.
Skills (S)
A. Core Skills/ Generic Skills
Writing Skills
The user/ individual on the job needs to know and understand how to: SA1. report/observation writing skills SA2. record and communicate details of work done to appropriate people using
written/typed report or computer based record/electronic mail SA3. maintain proper and concise records as per given format
Reading skills
The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements SA5. read notes/comments from supervisors and stakeholders SA6. disclose information only to those who have the right and need to know it
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA7. communication with upstream and downstream teams SA8. listen effectively and orally communicate information accurately SA9. communicate confidential and sensitive information discretely to authorized
person as per SOP
B. Professional Skills
Decision making
The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response
Plan and Organise
The user/individual on the job needs to know and understand how to: SB2. plan work assigned on a daily basis and provide estimates of time required for each piece of work
Analytical Skills
The user/individual on the job needs to know and understand how to: SB3. attention to details SB4. analyse data and activities SB5. pass on relevant information to members and supervisors SB6. identify and share improvements
Problem Solving
LFS/N0523 : Supervise and guide laboratory personnel
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The user/individual on the job needs to know and understand how to: SB7. seek clarification on problems from supervisors SB8. use effective problem solving techniques
Critical thinking
The user/individual on the job needs to know and understand how to: SB9. provide opinions on work in a detailed and constructive way SB10. apply balanced judgments to different approaches Customer Centricity
NA
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NOS Version Control
NOS Code LFS/N0523
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
LFS/N0525 : Assist in research activities
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National Occupational
Standards
Overview
This Occupational Standard describes the knowledge, understanding and skills required for a Scientist CRD to assist in research activities.
LFS/N0525 : Assist in research activities
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Unit Code LFS/N0525
Unit Title (Task)
Assist in research activities
Description This NOS is about a Scientist Clinical Research and development assisting in research activities.
Scope
The unit/task covers the following: 1. Developing new techniques.
Performance Criteria (PC) w.r.t. the Scope
Element
Performance Criteria
Developing new techniques
PC1. take necessary approval from the authorities before undertaking research. PC2. ensure that research follows the standard. PC3. identify information by categorizing, estimating, recognizing differences or
similarities, and detecting changes in circumstances or events. PC4. combine pieces of information to form general rules or conclusions
(includes finding a relationship among seemingly unrelated events). PC5. apply general rules to specific problems to produce answers that make sense PC6. concentrate on a task over a period of time without being distracted. PC7. understand the need and importance of research and the protocols for conducting
the same.
Knowledge and Understanding (K)
B. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. the importance of quality control procedures. KA2. characteristics of the product/material. KA3. knowledge of research techniques KA4. knowledge of data sources
B. Technical Knowledge
The user/individual on the job needs to know and understand: KB1. the correct method for carrying out corrective actions outlined for each
problem.
KB2. knowledge on different standard reference material.
KB3. role of different materials, chemicals and equipment. KB4. national/international standard test methods for different compounds.
KB5. knowledge of process information by compiling, coding, categorizing,
calculating, tabulating, auditing or verifying data.
KB6. evaluate the likely success of an idea in relation to the demands of the
situation.
KB7. knowledge and experience in hypothesis creation and data validation
activities
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Skills (S)
A. Core Skills/ Generic Skills
Writing skills
The user/ individual on the job needs to know and understand how to: SA1. make complete and accurate notes of the information and data gathered SA2. read, write and speak in English SA3. report writing and documentation skills
Reading skills
The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements SA5. read and interpret formulas and images, if any
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to: SA6. interact with people to effectively gather information SA7. listen effectively and orally communicate information accurately SA8. ask for clarification and advice from others
B. Professional Skills
Decision Making
The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response
Plan and Organise
The user/individual on the job needs to know and understand how to: SB2. plan work assigned on a daily basis and provide estimates of time required for
each piece of work SB3. ability to delegate work as per the strengths of individuals SB4. complete work within the proposed deadlines
Problem Solving
The user/individual on the job needs to know and understand how to: SB5. seek clarification on problems from supervisors SB6. use effective problem solving techniques
Analytical Thinking
The user/individual on the job needs to know and understand how to: SB7. analyse data and activities
SB8. pass on relevant information to members and supervisors SB9. identify and share improvements SB10. use of computer/application software SB11. use of quality management system/procedures SB12. attention to detail Critical Thinking
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The user/individual on the job needs to know and understand how to: SB13. provide opinions on work in a detailed and constructive way SB14. apply balanced judgments to different approaches Customer Centricity
NA
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NOS Version Control
NOS Code LFS/N0525
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 01/08/16
Occupation R&D Next review date 01/08/19
Qualification pack for Scientist Clinical Research and Development
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Annexure
Nomenclature for QP and NOS
Qualification Pack
9 characters
LFS/ Q 0101
LFS QP Number (2 numbers)
Q denoting Qualification Pack Occupation (2 numbers)
Occupational Standard
An example of NOS with ‘N’
9 characters
LFS/ N 0101
LFS OS Number (2 numbers)
Occupation (2 numbers)
N denoting National Occupational Standard
Qualification pack for Scientist Clinical Research and Development
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The following acronyms/codes have been used in the nomenclature above:
Sub-Sector Range of Occupation Numbers
Pharmaceutical and Biopharmaceutical and Contract Research
01-10
Pharmaceutical 11-20
Biopharmaceutical 21-30
Contract Research 31-40
Sequence Description Example
Three letters Industry name LFS
Slash / /
Next letter Whether QP or NOS Q//N
Next two numbers Occupation code 01
Next two numbers OS number 01
Qualification pack for Scientist Clinical Research and Development
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CRITERIA FOR ASSESSMENT OF TRAINEES
Job Role Scientist Clinical Research and Development Qualification Pack LFS/Q0507 Sector Skill Council Life Sciences Sector Skill Development Council
Guidelines for Assessment: 1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and Skills Practical for each PC. 2. The assessment for the theory part will be based on knowledge bank of questions created by the SSC. 3. Individual assessment agencies will create unique question papers for theory part for each candidate at each examination/training center (as per assessment criteria below) 4. Individual assessment agencies will create unique evaluations for skill practical for every student at each examination/training center based on this criteria 5. To pass the Qualification Pack , every trainee should score a minimum of 70% in every NOS 6. In case of successfully passing only certain number of NOS's, the trainee is eligible to take subsequent assessment on the balance NOS's to pass the Qualification Pack.
Marks Allocation
Assessment Outcome
Assessment Criteria of Outcomes Total Marks (800)
Out Of Theory Skills
Practical
LFS/N0522 (Carry out
investigation)
PC1. examine and analyze at microscopic, chemical and molecular level the body fluids and cells to look for bacteria, parasites, and other microorganisms.
100
10 5 5
PC2. inoculate cultures carefully needed to identify bacteria
10 4 6
PC3. analyze the chemical reactions to determine concentrations of compounds such as blood glucose and cholesterol levels
10 4 6
PC4. monitoring the effects of medication by testing how a patient is responding to treatment
10 3 7
PC5. perform tests in all sections of the laboratory including haematology,bacteriology,chemistry,urinalysis,serology,immunohematology,forensicpathology,immunology,and toxicology
10 4 6
PC6. ensure the conditions required for the maintenance of sample
5 2 3
PC7. perform some non-automated and specialized laboratory procedures
5 2 3
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PC8. follow set procedures to deal with contingencies arising during investigations
5 2 3
PC9. identify blood groups and cross matching blood for transfusions
5 2 3
PC10. determine the presence of normal or abnormal components by physical examination, laboratory testing and through diagnostic imaging techniques including radiography and ultrasound
10 4 6
PC11. testing of samples using molecular diagnostics and highly involved microbiological and cross-matching blood tests
5 2 3
PC12. identify factors which may prevent or alter specific disease
5 2 3
PC13.identifytypesand uses of vaccines in the prevention of infection
5 2 3
PC14.develop and implement new tests and methodologies as required
5 2 3
Total 100 40 60
LFS/N0527 (Conduct clinical
Trials)
PC1. conduct in vitro i.e. test tube or cell culture experiments
100
10 4 6
PC2. conduct in vivo i.e. animal experiments
10 4 6
PC3. use wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information
8 4 4
PC4. assess whether a drug candidate has scientific merit for further development as an investigational new drug
8 3 5
PC5. establish the dose range tolerated by volunteers for single and for multiple doses
8 4 4
PC6. conduct all the phases of clinical trial
8 4 4
PC7. gather preliminary data on the pharma co dynamics (what the drug does to the body)and pharmacokinetics(what the body does to the drugs)
8 4 4
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PC8. assess the safety( pharma co vigilance), tolerability, pharma co kinetics, and pharma co dynamics of a drug
8 3 5
PC9. determine a safe dose range 8 4 4
PC10. identify and monitor side-effects of the drug
8 3 5
PC11. provide regulatory submission i.e. Comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life for review to the appropriate regulatory authorities
8 4 4
PC12. detect any rare or long-term adverse effects over a much larger patient population and longer time period
8 4 4
Total 100 45 55
LFS/N0524 (Conduct analysis and interpretation
of data)
PC1. identify the appropriate analytical process to be used to analyze the data and consult with relevant people, gathering all the data relevant to the analysis
100
10 5 5
PC2. prepare the statistical analysis plan, which describes the proposed analysis in detail
10 4 6
PC3. ensure the presence of the data and information required to perform the analysis
5 2 3
PC4. collate all the data required for the analysis
8 4 4
PC5. review the data and information to select the methodology required to analyze the data
10 5 5
PC6. performing quality checks on the data accordance with organizational policies and procedures
5 2 3
PC7. compile the results of the analyze and check for any variances in the data
10 5 5
PC8. report any variances to the appropriate people and deal with them in accordance with organizational policies and
6 3 3
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procedures
PC9. carryout statistical and graphical methods to present the results of the analysis
10 4 6
PC10. carryout the report writing within the agreed timeline
10 4 6
PC11. issue the report, requesting feedback from the agreed people reviewing the report
5 2 3
PC12. ensure that amendments are made in line with organizational policies and procedures
5 2 3
PC13. issue the final report to the relevant personnel
6 3 3
Total 100 45 55
LFS/NO523 (Supervise and
guide laboratory personnel)
PC1. inspect equipment, structures, or materials to identify the cause of errors or Other problems or defects
100
8 3 5
PC2. Generate or use different sets of rules for combining or grouping things in Different ways
8 4 4
PC3. ensure the relevant policies and procedures followed in the organization
8 4 4
PC4. report any variances to the appropriate people and deal with them in accordance with organizational policies and procedures
7 3 4
PC5. supervising, training and/ or directing laboratory technicians, assistants, or other medical laboratory workers engaged in laboratory testing.
8 3 5
PC6. deal with people at junior levels to effectively direct their work towards Optimum output
8 4 4
PC7. analyse the training need of laboratory personnel
7 3 4
PC8. selectand prepare training and instruction resources to deliver the activities
8 4 4
PC9. training laboratory personnel on GLP
8 4 4
PC10. guiding laboratory personnel on new automated laboratory techniques
8 4 4
PC11. monitor and refine training 8 3 5
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activities to improve the trainee's attainment of required scientific or technical skills
PC12. supervising the team of laboratory personnel in carrying out advanced Testing and in dealing with highly automated equipment
7 3 4
PC13. communicating with other team members and people internal or external to the organization
7 3 4
Total 100 45 55
LFS/N0525 (Assist in research
activities)
PC1. Take necessary approval from the authorities before undertaking research
100
12 6 6
PC2. ensure that research follows the standard
12 6 6
PC3. Identify information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events
20 8 12
PC4. combine pieces of information to form general rules or conclusions(includes finding a relationship among seemingly unrelated events)
20 8 12
PC5. apply general rules to specific problems to produce answers that make sense
12 4 8
PC6. concentrate on a task over a period of time without being distracted
12 4 8
PC7. understand the need and importance of research and the protocols for conducting the same
12 4 8
Total 100 40 60
LFS/N0526 (Work with cross functional teams for carrying out
research activities)
PC1. Working effectively with other people who can be part of the immediate team, organization or external to the team or organization To meet requirements
100
16 8 8
PC2. sharing information with others to enable efficient delivery of work
20 10 10
PC3. communicating with other team members and people internal or external to the organization
20 10 10
PC4. provide and receive support and feedback from others in the team
20 10 10
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PC5. work with bio statistician, scientists in the other field and from different regions collaboratively to develop study design and pursue research further.
24 12 12
Total 100 50 50
LFS/N0102 ( Carry out
reporting and documentation)
PC1. report data/problems/incidents as applicable in a timely manner
100
10 5 5
PC2. report to the appropriate authority as laid down by the company
10 5 5
PC3. follow reporting procedures as prescribed by the company
10 5 5
PC4. identify documentation to be completed relating to one’s role
10 5 5
PC5. record details accurately in an appropriate format
10 5 5
PC6. complete all documentation within stipulated time according to company procedure
10 5 5
PC7. ensure that the final document meets regulatory and compliance requirements
10 5 5
PC8. make sure documents are available to all appropriate authorities to inspect
10 5 5
PC9. respond to requests for information in an appropriate manner whilst following organizational procedures
10 5 5
PC10. inform the appropriate authority of requests for information received
10 4 6
Total 100 49 51
LFS/N0101 Maintain a safe,
healthy and secure working
environment
PC1. observe and comply with your company’s current health, safety and security policies and procedures
10 5 5
PC2. while carrying outwork, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines
10 5 5
PC3. report any identified breaches in health, safety, and security policies and procedures to the designated person
10 5 5
PC4. responsible for maintaining discipline at the shop-floor/production area
10 5 5
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PC5. identify and correct any hazards that you can deal with safely, competently and within the limits of your authority
10 5 5
PC6. adhere and comply to storage and handling guidelines for hazardous material
10 5 5
PC7. identify and recommend opportunities for improving health, safety, and security to the designated person
10 5 5
PC8. complete any health, safety and security records legibly and accurately
10 4 6
PC9. report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected
10 4 6
PC10. follow your company’s procedures promptly, calmly and efficiently.
10 5 5
Total 100 48 52