Clinical Research Staff Survey Results: Current Insights and Future Directions

1. Clinical Research Staff SURVEY RESULTS • 40 Responders • 5-8 years avg. number of years in a CRC functional role • 40% certified by SoCRA, 2% ACRP • 57.5% not currently certified • Avg. of 3-10 studies at one time • Supports 3-5 avg. # investigators

2. FORMALIZED NETWORK • Overwhelming interest: 97% • Benefits: • 82% Education/Training, • 80% Career advancement • 68% Networking • 51% Certification Program For discussion: begin establishing the foundational principles of such networking organization based on the examples from UPenn and CHOP

3. CRC RESPONSIBILITIES • 94% Informed consent • Only 22% works on contract/budget negotiations • Top 3 responsibilities includes: -AE reporting 89% -Managing subject visits 86% -Recruitment 78% • 59% were assigned tasks appropriately

4. HIGHS 1.Patients/Subjects: ability to interact and offer additional medical care and access to cutting edge treatment and therapy options. 2. The ability to be a part of a team to bring new drugs to market 3. Flexibility (schedule)

5. LOWS • Length of time for IRB approvals and modifications • PI availability • Lack of adequate office space • Insufficient staffing/resources • Lack of funding • 57% paid own membership fees • 38% felt to have access to adequate resources • Where to seek help? 71% Colleague, 68% Supervisor, 63% IRB, 49% CTSC

6. LOWS • Job overload Avg. of 3-10 studies at one time • Supports 3-5 avg. # of investigators • 59% were assigned tasks appropriately • Lack of training esp. resolving billing issues • 35% felt properly trained for job-related tasks • Inadequate monitoring from CRO requires CRC to self audit

7. JOB TRAINING • 35% were properly trained for job-related tasks • Areas with insufficient training: • BILLING RESOLUTION • IRB SUBMISSION • CONTRACT/BUDGET • Additional resources: 71% colleague, 68% supervisor,63% IRB, 49% CTSC For discussion: improving job-related training

8. OTHER RESOURCES • Mentor • Google/internet • Cooperative groups • Books

9. MENTORING PROGRAM • 69% want such program available: • But, only 38% interested in being a mentor • Mentee’s goals: • assess current level of knowledge • access to education and training, • increased comfort level in job responsibilities For discussion: CTSC-based mentoring program

10. PI involvement • 29% Received useful and constructive PI feedback • 32% PI active role in CRC’s professional development and advancement • 68% PI/department financially supported outside training For discussion: ideas to increase PI involvement

11. REASONS FOR LEAVING CURRENT JOB • 53% found job to be professionally fulfilling • Opportunity for career advancement • Better pay$$$$ • Lack of job security due to loss of grant/funds • Stress/Job Burnout For discussion: ideas for improving job satisfaction and staff retention

12. Summary – for discussion • Interest in a more formalized organization for clinical research staff • Governance • Membership • Workgroups • Events • Improving job-related training • Defining CTSC-based mentoring program • Increase PI involvement • Improving job satisfaction and staff retention