Best Practices for Hiring and Training Clinical Research Coordinators

Presented by:

Erin Pennington, Product Manager

Huron Consulting Group

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Objectives

• Identify real-life challenges to hiring and training qualified research coordinators

• Provide food-for-thought in evaluating your current training programs and methodologies

• Provide some basic adult learning theories to improve success of training programs

• Suggest some best practices to train new staff and retain top performers

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The real-life problems

• True cost of staff turnover?• How many processes come to a

halt or breakdown when you lose a key performer?

• How much time do you spend on your top performers career development versus performance management of low performers?

• How many metrics would be improved if we didn’t spend so much time re-training?

• How often have we failed to act on low performers simply out of fear of trying to replace them.

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Does this sound familiar?

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Ever heard this feedback on a new hire?

“She is a total idiot”

“Not a good fit”

“They just don’t get it!”

“Don’t put them on my studies”

“They have no common sense”

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A Little Analogy

A new employee is like a bucket you need to fill. When you start “pouring” the knowledge in, if you pour too

fast, sometimes it spills out and you have to do it again.

To get all the water in carefully without spilling, it can take a long time.

But if there is a big hole at the bottom of the bucket, no method is going to work…and you need a new bucket.

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Bad Hire or Bad Training?

I have seen this scenario play out at every place I have ever worked.We developed a plan to attack the bad hire problem.

• Ask more people to interview• Ask behavioral- type questions• Pre-performance testing

We had some success but we still had bad hires.

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Bad Hire or Bad Training?

We tried more suggestions:• Centralized training resource• Standard forms and checklists• 30, 60 and 90 day orientation progress report• Competency checklists

All with success but it still seemed we were unreliably able to predict if our new hires would be successful in the first year and beyond.

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That pesky real-world again….

• Key things to keep in mind:• You can’t avoid all bad hires but you should aim to identify them

as early as possible to not burn out the good ones.• Research managers sometimes suffer from “we have a form for

that” syndrome and more paperwork is rarely the answer to a problem. A new checklist isn’t always the answer.

• Despite best efforts the need to get the new person “functional” trumps the need to get them “trained” in the real world. Training programs need to be adaptable and practical given the type of research your organization performs and the pressures you are under.

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Adult Learning

I’m going to show you a 19-digit sequence and you will have 30 seconds to learn it, the order is not important.

SICFNNAIRIDCEBPAAII

Don’t Cheat….It’s only an example!

READY….GO

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Did you get it?

What strategies did you use?

How many letters did you get?Did you try to make meaning out of it?

AAABCCDEFHIIIINNPRRS

SICFNNAIRIDCEBPAAII

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Let’s try again

Once Again….

SICFNNAIRIDCEBPAAIIBut let me present the information in a different way?

SAEIRBCRAFDANIHNCIPI

Any easier?

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How About Now?

SAE IRB CRA FDA NIH NCI PI

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Did you do better?

WHY?Did you become smarter?Was the sequence easier to learn?

“The same content, presented differently, creates a different impact on learning and retention”

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What is Learning?

Training• Tasks that should be reproduced without variation.

Instruction• Generalize beyond what was taught and produce thoughtful acts

Education• Result of life experiences and build general mental models. Implicit

messages via mentors and role models

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Ever get directions?

Have you ever gotten directions in a city you have never been to before?

• Local: Take East street south past McDonalds, turn left at the 3 way stop, just before the light at 2nd street, turn right. Well you don’t really turn, the road curves and then by the old school, turn left again.

• Lost Person: Where is East street?• Local: You’re on East Street?• Lost Person: But this sign says highway 31• Local: Yeah, East Street is Highway 31• Lost Person: Wait where do I turn again?

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What happened?

• You had an expert teacher• Both parties wanted a successful outcome

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The Answer

Who’s to blame?No one- When you “just know” it is not easy to tell someone how to do something. If you doubt this- try teaching a teenager to drive!Why?Because Procedural Knowledge and Declarative Knowledge are not easily transformedWhat does that mean?It means your expert “best CRC”….may not make the best trainer for your new staff.

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Key Ingredients

3 key ingredients for learning: • Ability• Motivation• Prior knowledge

– Benner’s Theory of Nursing Practice Stageso Novice, theoretical knowledge applied with objective ruleso Advanced beginner, begins to be able to apply situational aspects to ruleso Competence, gains hierarchical perspective and can apply situational rules. Starts

to feel responsible for decision making.o Proficient- applies experience in intuitive wayso Expert- not only knows what needs to be achieved but how to achieve it.

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Knowles 4 Principles

READINESSYou can’t fill a bucket that’s upside down

AUTONOMYSchool days are over, adult learner’s need autonomy

and independence

EXPERIENCEYou have to consider the learner’s prior experience

ACTIONThe best training not put into action is soon

forgotten.

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Take inventory

Receptive Approach• “Learning is not a spectator sport” - D. Blocher

– Examples: Powerpoint slides on “The informed consent process”– Telling information- making employee aware of information– Has its place for short, consciousness-raising sessions but should be limited– Not useful for gaining procedural knowledge

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Other Approaches

Directive Learning• Example: “Review Informed consent policy and answer related

questions”• Trainer organized content with active learning activities.• Control resides with trainer• Best for persons with little prior experience with content

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Other Approaches

Guided Discovery• Example: provide patient background scenario, a consent, a

protocol, the ICD policy and ask employee to discuss how they would approach the patient.

• Control is shared between learner and trainer• Generally case-based• Learners have to discover what to do using the trainer for

confirmation, debriefing • Trainer can add nuances and variations • Great for building confidence

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Other Approaches

Exploratory Learning• Example: Provide protocol materials and policies. Ask learner to

prepare for mock informed consent session.• Learning is individualized• Trainer is there for feedback and support• Resource intensive, decreased trainer control• Powerful for capable learners• Great for competency demonstrations

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Suggestions for improvement

• Review existing receptive tools to see how valuable they are and add active learning where able

• Look at procedural knowledge areas and focus on developing enhanced content for these areas.

• Evaluate the person who delivers the content. Do they have the time to devote, what level are they at?

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Suggestions for training enhancements

Already spent significant time on your training program?• You can add some simple activities to keep learners engaged and move away

from receptive training materials– Racing: after review of CTMS have learners race to find prompted information

or click contest to see who can find the information with the fewest clicks– Concentration game: matching research form to purpose– Confrontation: mock session of monitor or patient encounter situations– Critical Lists- following instruction on large amount of content .e.g. GCP, ask

employees to come up with 5 critical points. Each team/person gets a point for others that select the same item.

– Hit or Myth- variation of true false quiz focusing on common myths about research or processes

– Jeopardy Game- great for entire staff review– Scavenger Hunt- great for new employees to find their way around after tour or to

learn to utilize office resources. Better in groups.

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Tools for Game Creation

http://people.uncw.edu/ertzbergerj/msgames.htm

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Other Suggestions

To test or not to test?• Testing is a natural part of learning• 20% of adult learners are stressed by test taking regardless of

comfort level with content• Procedural knowledge is best tested with competencies• Consider use of behavioral checklist instruments for feedback

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Testing examples

CTCAE Grading PracticeUsing the current version of the CTCAE grading grade the following events. Hypertension of 150/80 AND requiring more than one oral therapy is a grade: ______ What section can you find fatigue under? __________________Thrombocytopenia with platelets of 70, this is a grade: __________Elevated AST of 76. The normal range is 10-35. This is a grade: __________Patient was diagnosed with insomnia at baseline. At which time they had trouble sleeping occasionally but able to continue to work. At this visit patient reports having difficulty sleeping which results in several daily naps and makes it difficult for him to focus. _________Protocol states patients must have ANC greater than 1000/ mm^3 in order to receive treatment. On Day 1 your patient has grade 3 ANC, can they receive treatment? _________ For subject eligibility patient Hemoglobin must be ≥ 7.0. Your patient at time of consent has Hemoglobin, defined as grade 2. Is she eligible for your trial? _________Patient has erythema of the feet making it painful to walk, but patient is continuing with her daily activities. Upon appearance it is red and flaky skin. What can you most likely grade this event? __________Patient reports under the direction of his PCP he has started taking medication because he was having difficulty getting an erection. Find the AE terminology for this complaint and grade it. __________________ Grade: _________Patient with lung cancer presents with difficulty breathing. Upon questioning her you find she can not walk to her mailbox or up a flight of stairs without stopping. Find AE term _____________________. Grade: ___________

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CTMS Scavenger Hunt

• How many phase II breast cancer protocols does Dr. Smith have open to accrual? Attach the cover page for the most recently opened trial?

• What is the name of the first consented patient on protocol CA184555? Find the consent, did she/he consent to biomarker testing?

• How much is the reimbursement for the baseline visit on Dr. Miller’s newest open protocol? Locate the financial file and record the date of contract execution?

• How many SAE’s occurred on JXYZ protocol, find a copy of the SAE report that occurred on March 10, 2009.

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Assessing Competency

Behavior Checklist• SAE

Documented in File Sponsor form completed and submitted Reported to IRB if serious, unexpected, and related

Binary Test• SAE’s must be reported to the IRB if they are related, unexpected and serious? T

or FShort Answer Assessment

• Name the criteria for reporting an SAE to the IRB?True Competency and Performance Verification Review

• Review of SAE for appropriate reporting. Performance Verification checklist to outline mental steps.

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True Competency Example

At notification of an SAE, Employee:• Identified applicable reporting criteria in protocol?• Requested all outside records and took steps to obtain preliminary information?• Ensured PI was aware, initiated conversation of potential relationship to study agent?• Documented known information on sponsor provided form and submitted in required

timeframe?• Took steps to obtain unknown information and made sponsor aware of unknown

information?• Reviewed protocol for potential treatment implications and communicated findings to

research team?• Documented event in CTMS?• Reviewed event for expectedness by referencing consent and IB as applicable?• Reported event to IRB or documented reasoning not reportable?

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Testing Competency- Final Thoughts

• Keep objectives in mind- what level of recall and procedural knowledge is truly needed?

• Avoid negatives and double negatives• Start with easy questions to minimize anxiety• Don’t test memorization, test comprehension• Try out test before implementing• Make competency assessment as applicable to real life

scenarios as possible.• Limit Use of terms “test”, “exam”, “evaluate” and “measure”

in favor of “practice”, “self-check” and “game”

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Documenting Training

• GCP requires “qualified research staff”• Aware of regulations and how they apply• Competent to perform what they have been delegated• Acceptable standards for conduct of clinical trials and human

subject protection• Data collection- sufficient skill, knowledge and experience to

transcribe data accurately• Documentation of training is essential component of training program• Ensure meaning of signatures are identified• Ensure job descriptions are in-line with training materials.

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The non-licensed coordinator

• Be very aware of non-licensed individuals performing medical study related procedures

• Common examples: vital signs, blood draws, EKG’s • Evaluate scope of practice issues and permissible delegations-

have a written policy on these• Ensure that training includes what they are not permitted to do

so there is no confusion and/or pressure. – Licensed professional are very comfortable pushing back when they are

asked to do things out of their scope, however, non-licensed CRC’s may not feel as comfortable or appreciate when they are not qualified

– State regulations may vary here.

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Adult Learning myths

MYTH FACT

Experts are the best trainer Best Trainers are in the competent stage

It is important if you are dealing with an auditory or visual learner

Learning is best absorbed if multi-sensory

The more enjoyable training is, the better Persistence and time on task are critical variables. Enjoyment helps with persistence

Working out problems on your own leads to better performance in problem solving

Providing learners with partially worked out problems and guiding them through trouble shooting is better

More is better Less is more

Lack of performance is from lack of skills Lack of performance may be due to lack of clarity in expectations, inadequate feedback, limited resources

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Retention

• Don’t get into a vacancy snowball• Pay attention to the top performers!!!

• Make sure they are learning and growing• Offer meaningful levels/career advancement• Treated as professional members of the team• Paid fairly based on experience and market value

• Training is not a day 1, week 1 or month 1 process• Allow for, encourage and reward continuing education efforts

• Look at cross training issues• Do your coordinators feel they can take a day off?• Temporary staff, part time fill in’s available

Conclusions from people who know more than I

For learning to take place with any kind of efficiency students must be motivated. To be motivated, they must become interested. And they become interested when they are actively working on projects which they can relate to their values and goals in life. - Gus Tuberville, President, William Penn College

The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires - William Arthur Ward

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References

Stolovitch H, Keeps E. 2002. Telling Ain’t Training, New York: ASTD Press.Benner, P et al 2009. Expertise in Nursing Practice 2nd Ed. New York: Springer.Knowles, M. 1975. Self Directed Learning-A guide for Learners and Teachers. New York: Associated Press. Clark, R.C 1994. The Causes and Cures of learner overload. Training, 31 (7), 40-43.

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