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