Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases.

There are no certification or degree requirements to work as a clinical research professional either.

To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast.

Erika advises life sciences, academic medical centers, hospitals, cancer centers, foundations and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance. 

She has over 20 years of research/ R&D experience, serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. 

Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University.  She also holds a Graduate Certificate in Gerontology from Case Western University.

Please join me in welcoming Erika on the show.

Podcast Sponsor(s):

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

Referenced Works:

Erika Stevens LinkedIn

Rutgers School of Health Professionals

Association of Clinical Research Professionals (ACRP)

Journal of Obstetrics and Gynecology

Journal of Mental Health and Aging

Vermont University

Case Western Reserve University

Temple University

Department of Labor (US)

Harvard University

Public Responsibility in Medicine & Research PRIM&R

Human Care and Compassion Association (HCCA)

Regulatory Affairs Professional Society (RAPS)

Food and Drug Administration – FDA (US)

Good Clinical Practice (GCP)

Good Laboratory Practice

Health Insurance Portability and Accountability Act (HIPAA)

Collaborative Institutional Training Initiative (CITI)

Society of Research Administrators International (SRAI)

Bureau of Labor Statistics (BLS)

Society of Clinical Research Associates (SOCRA)

PPD: Global Pharmaceutical Contract Research Organization (CRO)

Columbia School of Medicine 

Dartmouth-Hitchcock Medical Center

Human Research Protection Program (HRPP) 

Academic Medical Centers (AMCs)

Continuing Education Unit (CEU)

Continuing Medical Education (CME)

Boston Medical Center NICU

Joint Task Force Clinical Trial Competency 

Multi-Regional Clinical Trials Center

People: Kenneth Getz

CenterWatch

PubMed

National Institutes of Health (NIH)

Referenced Books:

CRC’s Guide to Coordinating Clinical Research – Karen Woodin (Amazon)

Clinical Research Coordinator Handbook – Deborrah Norris (Amazon, Barnes & Noble)

Source Book for Clinical Research – Martine & Milligan (Amazon)

Designing Clinical Research Fifth Edition – Warren S Browner MD MPH, Thomas B Newman MD MPH, Steven R Cummings MD, Deborah G Grady MD MPH, Alison J Huang, Alka M Kanaya, March J Pletcher (Amazon, Barnes & Noble, Wolters Kluwer)

Show Notes:

[4:27] The importance of having a clinical research professional in the U.S. Department of Labor 

• Clinical Trials aren’t as recognized as other industries historically
• Perception has changed a lot from the 80s to today
• Clinical research professionals aren’t a recognized profession unlike physicians and bench scientists which are recognized
• Need broader industry wide push to get clinical research professionals recognized by the Department of Labor
• Lack of industry standardization presents a challenge

[9:41] What is the Association of Clinical Research Professionals (ACRP) is pushing for right now?

• Desire to get jobs recognized with outline of the skills required for different roles
• Standardization to bring about a standard vernacular across the industry
• Standardization to improve public understanding of what clinical research professionals do
• After core competencies are defined, we need to validate they are the correct ones for specific research roles

[13:12] Bringing About Public Awareness of Clinical Research Careers

• Media activities like the podcast
• Educational programs
• Highlighting the current clinical research workforce shortage
• Create access to training and development resources
• Eliminate arbitrary career barriers

[18:40] Multi Regional Clinical Trials Task Force

• Came out of Harvard and collaborating institutes – established 8 domains as critical domains
• Try to parse out the key skills involved in clinical research careers
• Attempt to create a pathway to mastery within each domain
• Research is conducted along a continuum and research staff participate in certain or all parts of at that continuum
• Important to establish both regulations and skills needed which coincides with competency base training
• Goal of elevating talented people within the industry to elevate them and meet the current workforce shortage

[23:58] Clinical Research Workforce Shortage

• Need for people with minimum 2 years experience
• Historic disconnect in understanding between research staff like nurses and new roles like research coordinators
• Need to set up new staff with preceptors that help to train them up to their roles similar to how nurses have done historically
• Different member organizations help people entering this profession to specialize based on their desired expertise
• Still a lack of uniformity in what the industry wants for different roles. Example: Licenses are nice to have but not a requirement like they are for healthcare professional roles
• Example organizations: PRIMR, HCCA, RAPS

[37:02] Finding Training Modules and Specific Training for Research Professional Badging

• University programs are coming out like: Rutgers School of Health Professionals 
• CITI training offer a certain way of credentialing for things like GCP, HIPAA
• Online modules don’t provide a full hands on experience
• Badging systems through some academic institutes like Rutgers offer help to provide stronger training than limited online modules

[40:10] Sponsor Break: Veeva & Slope Clinical (https://sites.veeva.com/) (https://www.slopeclinical.com/)

[13:12] Clinical Research Badging

• Badging exists in many industries
• Digital badges provide certification of course completion
• Helpful in asserting on ones career profile/resume what training they have done for hiring mangers
• Badging focuses on different sub specialties like research coordination, data management, project management, etc.
• Badging trainings often conducted through Learning Management Systems

[51:40] Alternative Training Systems to CITI

• Society of Research Administrators International provides micro credentials which Erika worked with them to help developed
• Ideally programs should let you shadow experience to have a fully comprehensive understanding of different research functions

[54:19] Value of hands on training experience

• Brings home understanding created from doing course work
• Mitigates risk by letting people practice in a safe environment
• Until a core global standard is met there still will be challenges in designing the best training approach

[56:21] Are certifications alone sufficient? 

• BLS website list core competencies: communication skills, critical thinking skills, interpersonal skills, leadership skills, problem solving skills
• Still even with training and hands on that may not be sufficient experience
• Soft skills are just as critical as technical skills

[1:02:27] Erika discusses her developing manuscript on skills needed for clinical research professionals

• Leveraging a manuscript that looked at a large dataset for soft skills from job listings between 2010 and 2019
• Begs the question how does one develop their soft skills

[1:04:39] RAPS membership for clinical research professionals

• Understanding how it differs from other membership organizations such as ACRP, HCCA 
• Offers ability to operate in three (3) verticals
  • Clinical Operations
  • Regulatory Operations
  • Financial/ Administrative 

[1:08:17] Role of Clinical Trial Office at large academic sites

• Helps to facilitate some administrative burden off of the site investigators
• Creates opportunity for consistency 
• Reduces compliance risk
• Create efficiency 
• Improved data quality
• Support Industry Sponsored & Investigator Initiated Studies
• Alignment across study documents such as contracts, budgets, consent
• Revenue and expense management 

[1:13:01] Erika Stevens closing thoughts

• Need to continue to offer opportunities for workforce development and reduce barriers
• Industry is moving in the direction of competency and recognition of the profession
• Would love to see unilateral mandate from the FDA
• Everyone’s journey through this space will not be the same

[1:20:25] Resource/Book Recommendations

[1:27:01] Sponsor Break: Slope Clinical (https://www.slopeclinical.com/)