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Ken Getz

Executive Director, Tufts Center for the Study of Drug Development (CSDD)

Tufts University School of Medicine

Tufts Csdd Survey Results

Survey demographics

  • 55 Respondents
  • 21 Mean years of experience
  • 17+ Therapeutic areas represented
  • 17.5K Mean number of employees
  • 91% In clinical development / operations
  • 66% C -suite or head of function

Perceptions about the CRA industry shortage

  • 88% There is an industry shortage
  • 43% It’s getting worse
  • 57% It’s staying the same
  • 0% It’s getting better

CRA Education & Experience

  • 44% <2 years required
  • 35% 2 years required
  • 21% >2 years required
  • 79% Require a bachelor’s degree
  • 69% Have hired a CRA with < 2 years’ experience

Training Requirements

  • 62% College / university
  • 59% Company
  • 33% 3-4 months of training
  • 18% 1-2 months of training
  • 15% 5-6 months of training
  • 15% < 1 month of training
  • 84% Peer support / mentoring most effective training
  • 77% In person most effective training
  • 39% Experiential training most effective training

General areas of competency

  • Scientific concepts and research design
  • Ethical and participant safety considerations
  • Ethical and participant safety considerations
  • Investigational product development and regulation
  • Clinical study operations (good clinical practice)
  • Study and site management
  • Data management and technology
  • Leadership and professionalism
  • Communication and teamwork

Technical skills needed

  • Digital and remote solutions
  • Data literacy
  • Project management
  • Risk identification and mitigation development
  • Writing

Soft skills needed

  • Ability to escalate
  • Communication skills
  • Influencing and negotiating
  • Multitasking
  • Organization
  • Problem solving and strategic thinking
  • Professionalism
  • Resilience
  • Building site relationships
  • Managing stress

Recruiting approaches used

  • 86% Recruiters
  • 69% Website / social media
  • 59% Staffing companies

Recruiting approaches that are most successful

  • 52% Recruiters
  • 38% Internal staff referrals, recommendations, self-application

Average annual turnover rate

  • 25% 15-20% turnover
  • 22% ≤ 10% turnover
  • 16% 20-25% turnover
  • 13% 10-15% turnover

Reasons for leaving

  • 74% Better salaries
  • 45% Better growth opportunities
  • 29% Burnout

Retention strategies

  • 65% Flexible work schedules
  • 55% Higher salaries
  • 42% Sign-on bonus
  • 42% Enhanced benefits

Factors influencing CRA performance

  • 40% Type of training received
  • 35% Years of experience
  • 10% Mentoring received by senior CRAs
  • 10% Developing expertise outside of training

Moe Alsumidaie

Head of Research, Clinibiz and Chief Data Scientist, Annex Clinical

Tufts University School of Medicine

CRA Experience vs. Performance

Key findings

  • We studied 579 CRAs with varying degrees of experience within global CROs in geographies across the world
  • They received a mock study and monitoring visit scenario via simulation to capture monitoring issues
  • Across all experience categories, the average score difference was not statistically significant:
    • CRA experience does not appear to be associated with quality in an objective test
    • CRA experience does not appear to be associated with consistent results
    • Perhaps “CRA experience” is not a good performance predictor
    • CCRAs may be getting promoted due to experience and not performance
  • Regulations on training and experience (ICH-E6-R2):
    • They don’t focus on years of experience a monitor must have
    • They say that mnitrs “should be qualified by education, training, and experience”
    • They “should be appropriately trained, and should have the…clinical knowledge needed to monitor”
    • They “should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form…”
  • It’s time to rethink the two-year research experience requirement
  • CRAs move into higher positions because of their experience
  • The two-year barrier blocks qualified professionals with exemplary credentials to become entry-level CRAs
  • CRA siphoning and entry barriers contribute to the shortage
  • A better model for hiring CRAs:
    • Those with the necessary clinical education and experience (including outside clinical research
    • Experiential on-site support (in-person mentoring to support experience requirements, and technology
    • Experiential training curriculum in ICH-GCP
    • Regular performance testing for monitoring quality and consistency