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CLINICAL TRIALS DESIGN & MANAGEMENT PROGRAM
Presented by:
Karen Nelson Villanueva – Program LeadLily Vo – Program Coordinator
DISCLAIMER
You will be participating in an SF State event where audio and video is
being recorded.
By participating in this event, you consent to audio recording, video
recording and its/their release, publication, exhibition, or reproduction
to be used for news, web casts, promotional purposes, telecasts,
advertising on web sites, or for any other purpose(s) that SF State, its
vendors, partners, affiliates and/or representatives deems fit to use. You
release SF State, its officers and employees, and each and all persons
involved from any liability connected with the taking, recording,
digitizing, or publication of interviews, photographs, computer images,
video and/or or sound recordings.
You have been fully informed of your consent, waiver of liability, and
release before participating in this SF State Event.
PROGRAM OVERVIEW
Ever-evolving government regulations are putting a new focus on clinical trials in the pharmaceuticals, biologics, and biotechnology device industries. Our Clinical Trials Design & Management Program was created to help you become a successful member in clinical research operations and take advantage of an industry in need of qualified candidates.
From gaining a foundational understanding of the field to improving your overall value to biotechnology/pharmaceutical companies, the program is an ideal fit for career changers and enhancers.
Individuals who pursue a Clinical Trials Design & Management certificate from SF State Extended Learning are professionals, often with advanced degrees, working in science, health care, technology or management.
LEARNING OUTCOMES
The Clinical Trials Design & Management Program Certificate prepares students to
become clinical research associates or coordinators.
Our curriculum that covers core concepts, including regulatory affairs, biostatistics, clinical trials design, data
management and safety monitoring. The sequence of courses gives you skills that biotechnology and
pharmaceutical industry employers are looking for.
WHY ENROLL WITH US?
Convenient online program
Your own pace, up to 3 years
$4,790 for certificate
Taught by active
professionals
COURSE REQUIREMENTS
• Requires access to laptop/computer and internet connection
• Familiarity with iLearn• Comfortable with online learning
environment• Webcam & mic recommended
CERTIFICATE REQUIREMENTS
Once you have completed ALL
the necessary coursework,
submit the Certificate of
Completion Request Form:
https://cel.sfsu.edu/certificate-
request
Course # Required Course CEU
IT 9357 Overview of Clinical Development 1.8
IT 9358 Good Clinical Practices (GCP) 1.8
IT 9387 Clinical Trials Monitoring 1.8
IT 9388 Clinical Trials Design 1.8
IT 9359 Clinical Data Management 1.8
IT 9386 Biostatistics 1.8
IT 9531 Introduction to Regulatory Affairs (US) 1.2
IT 9539 Safety Monitoring 1.2
IT 9351 Clinical Project Management I 1.8
IT 9354 Clinical Project Management II 1.8
IT 9392 Case Report Form Design 0.6
OR
IT 9391 Compliance Audits/FDA Inspections 0.6
GET STARTED
All students will need an SF State ID & Password to enable registration and Payment at
College of Extended Learning. Use Quick Admit to obtain and SFSU ID and Password
https://cel.sfsu.edu/register/quickadmit
Overview of Clinical Development and Good Clinical Practices are prerequisites to all other
classes. Please contact us directly if you have any questions.
To access the online class, visit http://ilearn.sfsu.edu to log in after registration and
payment using SF State ID and password.
WAYS TO REGISTER
Register & pay online
with Gateway
Instructions:
https://cel.sfsu.edu/re
gister/gateway-
instructions
Complete the Registration
form:
https://cel.sfsu.edu/sites/de
fault/files/documents/regist
er/regform.pdf
Drop off the form at Main
Campus or Downtown
Campus
Complete the online
registration form, and you
will be contact within 24
hours
Link:
https://cel.sfsu.edu/register
/easy-form
Call (415-405-7700)
Hours: Monday – Friday,
9AM-5PM. Please have
your SFSU ID and Class
Numbers ready
PHONE ONLINE ONLINE – STAFF ASSIST IN PERSON
REGISTRATION
FACULTY
Bruno Gagnon
VP – Clinical Operations @
BioMarin Pharm Inc.
Siu Po Sit
VP – Clinical Affairs @
Penumbra Inc.
Michelle Gray
Sr. Director – Clinical
Operations @ a start up
Ron Lillie
Director – Drug Safety Data
Analytics @ Exelixis, Inc.
Tenea Nelson
Toxicologist @ Genentech
Thomas Tremblay
Sr. Director – Clinical Operations
@ a local sf company
Bethany Van Veen
Consultant for Bay Area
pharmaceutical companies
Fabio De Martino
Sr. Manager – Global Quality
@ Genentech
Peter Shabe
President @ Advance
Research Associates, Inc.
To learn more about each faculty and
their background, please visit:
https://cel.sfsu.edu/clinicalonline/faculty
