SoCRA - ATL Chapter Presentation (Career Transition CRC to ... · 5(48,5(0(176 )25 &&53...

PRESENTATION FOR ATLANTA CHAPTER OF SOCRA

CAREER TRANSITION:

COORDINATORS (CRC)

TOTO

MONITORS (CRA)

19 NOV 2016

Atlanta Premier SMO CC OneVision

GBOLAHAN FATUGA, MBA, PMP Executive Director ATLANTA PREMIER SMOFounder/President of CC ONEVISION

Tel: (678) 852-1355

Fax: (360) 287-9385

Email: [email protected]


OBJECTIVES

Key presentation objectives for attendees: Present an overview of CRA position

List advantages and disadvantages of the CRA position

Describe career path options for CRAs


Present a brief description of CRC position

Discuss challenges in making the transition from CRC to CRA

Identify resources to make the transition

OVERVIEW OF CRA POSITION

Universal term for individuals who monitor clinical trials

Interface between project team and investigators


Interface between project team and investigators

Clinical site monitoring

New drug development

Reviewing investigator’s budgets/contracts

Wearing multiple hats

CRA RESPONSIBILITIES

Oversee initiation, progress, and proper conduct of clinical trials

Ensure scientific integrity and quality of data


Ensure scientific integrity and quality of data collected in timely manner

Protect rights, safety, and well-being of human study subjects

Train and mentor new people Various clinical operations

CRA RESPONSIBILITIES (cont.)

Review CRF against subject’s medical record for completeness and accuracy

Ensure proper ICF process execution and


Ensure proper ICF process execution and documentation (highly common FDA 483 finding)

Ensure regulatory documents are filed and maintained

Properly document/report adverse subject experiences

CRA PERSONALITIES & SKILLS (IDEAL)

Attention to details Confident Flexible Team player

Time management Problem solver Self motivated Excellent listener Team player

Ability to interact well with people

Motivational skills Background in Life

Sciences

Excellent listener Good interpersonal

skills Strong communication

skills (verbal/written) Entrepreneurial skills


ADVANTAGES TO BECOMING CRA

Continuously improving career path

High employment opportunities (recruiters)

Lucrative salary

Ability to work independently


Ability to work independently For the most part, set your own schedule

Develop entrepreneur skills

Cutting edge of medical advancements and technology

CRA ADVANTAGES (cont.)

Travel to new places (domestically/internationally)

Meet bright and interesting people

Provide a GREAT services to our society Contribute to the development of new and innovative


Contribute to the development of new and innovative treatments

Improve people’s life

DISADVANTAGES TO BECOMING CRA

High turnover (usu. manager’s issues & travel)

Extensive travel

Difficulties to break into the industry

“Sink or swim” training concept (some companies)


“Sink or swim” training concept (some companies)

Expanding roles of CRA

Difficulties to retain, train, recruit, and manage CRAs

Challenges in maintaining work vs. family balance

TRAVEL REQUIREMENTS

CRA travel typically ranges 50-75% in first few years Lead CRA may travel less in exchange for more

management responsibilities


Excessive travel WILL lead to burn-out

Regional CRA THEORY: Travel within a certain region (e.g., New

England) to reduce cost and burn-outs

REALITY: High CRA turnover usually leads to acquisition of additional sites and increased travel

CAREER PREPARATION

Post-graduate courses in clinical research

Courses taught by professional societies

Register with job listing services www.career.com


www.career.com

www.indeed.com

Constant review of FDA regulations

Join clinical trial industry professional societies

Read industry magazines (e.g., Applied Clinical Trials)

A Day in the Life of a CRA


A Day in the Life Continued


CAREER PATH FOR CRAs

Employment Opportunities Sponsor companies Pharmaceutical/Biologics/Biotech companies

Contract Research Organization (CROs) – defineQuickest and roughest way to get experience


Quickest and roughest way to get experience

Typical Career Path Clinical Assistant CRA I (in-house) CRA II CRA

III/Lead CRA Regional (home-based) CRA CTM/Independent CRA Project Manager

INDEPENDENT MONITOR’S LIFESTYLE

Early mornings & late nights

High travel time

Working on several trials concurrently


Working on several trials concurrently

Responding to many emails and voice mails per day (50 – 100 daily)

Stress coping mechanisms Examples: reading, exercise, friends, etc.

CRC RESPONSIBILITIES

Screening patients

Managing patients’ scheduling

Informing subjects

Recording CRF data

Maintaining study files

Ensuring study supplies are properly Informing subjects

Preparing site for study implementation

are properly inventoried, stored, re-ordered

Transmitting data to sponsor


CRC PERSONALITIES & SKILLS (IDEAL)

Attention to details Confident Flexible Team player

Time management Problem solver Self motivated Excellent listener Team player

Ability to interact well with people

Motivational skills Background in Life

Sciences

Excellent listener Interpersonal skills Strong communication

skills (verbal/written) Strong patient

interaction skills


CHALLENGES OF TRANSITION

Proof of transferable skills from CRC to CRA Full understanding of the circular relationship

between investigational site and sponsor Lack of CRCs in the clinical trial industry will hamper

clinical trial process (ticking off PIs)


clinical trial process (ticking off PIs) Effective use of recruiters Companies are moving away from hiring entry-level

people Family/personal constraint (travel factor)

RESOURCES TO MAKE TRANSITION

Recruiters (highly recommended)

Professional societies (e.g., SoCRA, ACRP, DIA)

Industry focused career websites www.medzilla.com


www.medzilla.com

www.centerwatch.com

Networking (e.g., www.linkedin.com) - IMPORTANT

Appropriate marketing (resume/interview skills)

Continuing education/industry certification

Salary Information (e.g., www.salary.com)

WORKING WITH RECRUITERS

Target multiple companies

Offer insider’s perspectives on companies

May assist with salary negotiation

May assist with interview preparation


May assist with interview preparation

Motivated by potential commission

Many pharmaceuticals/CROs Exclusive use of recruiters

Preferred use of recruiters to screening candidates

HIGH DEMANDS

Qualified CRAs (at least 2-3 years of monitoring)

Monitors in non-traditional hubs

Specific technology experience

Therapeutic experiences


Therapeutic experiences Specialized therapeutic experience

Multiple therapeutic experience

Oncology experienceOncology monitoring

Oncology nursing

EMPLOYER INCENTIVES

Interesting assignments

Training & career development

Supportive culture

Organization of a regional staff


Organization of a regional staff Best regional system: Regional management & 2-3

times in-house training (internal networking)

Flexibility in being 100% dedicated to a project Retention of employees; reduce burnout

REQUIREMENTS FOR CCRP CERTIFICATION

The applicant must be working with GCP guidelines under IRB approved protocols

The applicant must meet one of the following Eligibility Criteria noted below: Category 1: 2 years of experience as a full-time Clinical Research


Category 1: 2 years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last 5 years

Category 2: Degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program AND have completed a minimum of 1 year of full-time experience (or 1,750 hours part-time) during the past 2 years as a Clinical Research Professional

Category 3: Clinical research professionals with 2 years full time experience, who have in-depth knowledge of the field CRA job functions (e.g., In-house CRA, Medical Liaison, etc.)

REQUIREMENTS FOR CCRP CERTIFICATION

Refer to SoCRA’s CCRP Certification Guide (https://www.socra.org/certification/ccrp-certification-exam/exam-overview/ ) for complete requirements.


QUESTIONS TO ASK DURING INTERVIEW

What is the ideal candidate for this position?

What internal career growth opportunities are available for this position?

How many protocols does a CRA typically cover


How many protocols does a CRA typically cover concurrently?

How many sites does a CRA typically manage concurrently?

What professional development/training opportunities are available?

CONCLUSION

Differences in CRA role in last 10-20 years Salary, responsibilities, regionalization, technology

Required personalities/skills of an effective CRA

Market, market, and market yourself


Market, market, and market yourself Emphasize transferable skills from CRC to CRA

CONCLUSION (cont.)

Revisit key objectives of presentation: Presented overview of CRA position

Listed advantages and disadvantages of the CRA position

Described career path options for CRAs


Presented a brief description of CRC position

Discussed challenges in making the transition from CRC to CRA

Identified resources to make the transition

REFERENCES

Applied Clinical Trials (ACT) Magazine (www.actonline.com)

CenterWatch: Monitoring Changes among CRA by Susanna Space (July 2003, Volume 10, Issue 7)

CRA’s Guide to Monitoring Clinical Research by K. Woodin & J. Schneider.

pubs_profs_craguide.html


CRC’s Guide to Coordinating Clinical Research by K. Woodin & J. Schneider.

www.centerwatch.com/bookstore/pubs_profs_crcguide.html

CRC Handbook GCP Tools and Techniques by D. Rosenbaum

Foundations of Clinical Research, 3rd Ed.

www.centerwatch.com/bookstore/pubs_profs_fcr.html

Guide to Clinical Trials by B. Spilker

REFERENCES (cont.)

PharmaVoice: The CRA – Key to Site Effective by Denise Myshko (Sept. 2005)

The Ultimate Step by Step Guide to Conducting Pharmaceutical Clinical Trials in the USA

www.raninstitute.com/books.php

www.acrpnet.org

www.careers.biospace.com


www.careers.biospace.com

www.centerwatch.com

www.fda.gov

www.ibpassociation.org

www.linkedin.com

www.medzilla.com

www.salary.com

www.socra.org

SoCRA - ATL Chapter Presentation (Career Transition CRC to ... · 5(48,5(0(176 )25 &&53...

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