1. The Principal Investigator Role: How to Avoid Conflicts with the Research Coordinator
Giora Weisz, MD
Director of Cardiovascular Clinical Research,
Center for Interventional Vascular Therapy
Columbia University Medical Center
Cardiovascular Research Foundation
New York, NY

2. Giora Weisz, MD Tryton Medical, Inc. Consulting: InfraReDx, Inc.
Svelte Therapeutics
Philips Medical Systems, Inc.
Stocks, Stock Options, other ownership interest:
Simbionix
Bloxr
Sync-RX

3. Columbia University Medical Center Center for Interventional Vascular Therapy
My Dream Team
Thank You!

8. Who are the research coordinators?
The people that make clinical research happen!
Screen for eligible patients, follow the procedure, fill the CRF, answer to queries, and take the hit from the monitor
Enthusiastic workers the PI hire to help him

9. Who are the research coordinators?
People that make career in research
Nurses with many years in clinical experience
Post college, pre-medical school

10. Not in front of the patients, please

11. Who are the PIs? Interventional cardiologists
Interested in research, new echnology / pharma
Busy, busy, busy
Want to be the No. 1 enroller in the world
“Publish or perish”

13. The Managerial Balance

14. Communication

16. 9/3/2018
Case Study 1
There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC s requesting an appointment to complete. You:
TCT DRAFT

17. 9/3/2018
Case Study 1
There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC s requesting an appointment to complete. You:
Do not respond to the
TCT DRAFT

18. 9/3/2018
Case Study 1
There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC s requesting an appointment to complete. You:
Do not respond to the
Respond to catch you between cases in the cath lab. When the RC shows up make them wait for hours
TCT DRAFT

19. Case Study 1
9/3/2018
There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC s requesting an appointment to complete. You:
Dr A did not respond to the
Dr B asked to catch you between cases in the cath lab. When the RC shows up make them wait for hours
Dr Weisz scheduled a one-on-one meeting to complete together and sign any pending items
Obviously C is the correct answer but A and B happen frequently and lead to disgruntled employees, poor data quality, etc.
TCT DRAFT

20. Case Study 2
The RC receives a telephone call about a critical lab value (CK-MB >3x ULN) and s you to notify and receive instructions on how to proceed.

21. Case Study 2 Scenario A: PI unresponsive to initial email
9/3/2018
Case Study 2
Scenario A:
PI unresponsive to initial
After the 2nd follow up the PI responds with “ok” and no plan of action
Requests the RC contact the patient
The late documentation is flagged during a monitoring visit and the PI claims no knowledge of the event
The RC is looking for a new job
RC does not have a medical license so should not discuss implications of clinical information
TCT DRAFT

22. Case Study 2
Scenario B:
PI reviews most recent ECG and previous labs (if available)
Further review of medical record if necessary
Calls patient to inform them and provides a follow up plan
Documents steps for source
The RC adores the PI, and swear to be on his side until his last day

23. Top 10 Ways to Avoid Conflict
9/3/2018
Top 10 Ways to Avoid Conflict
Stay in constant/good communication
Create a team atmosphere
Daily oversight
Allow for independence of the RC
Give credit where credit is due
1-be aware of data deadlines, outstanding action items, troubles with recruitment and retention
2-involve the RCs in the decision making which makes them feel invested in the project. Our RCs recently expressed interest in the budget process so we started incorporating them
5-when possible include the RC as authors on papers
TCT DRAFT

24. Top 10 Continued… Encourage career development
9/3/2018
Top 10 Continued…
Encourage career development
Address issues immediately and without emotion
Set an example
Positive reinforcement
Have a sense of humor
6- Many RCs are using the job as a stepping stone between undergrad and medical/PA school. Therefore RCs appreciated training sessions and grand rounds. Help write letters of recommendations.
You can also mention that we do quarterly outings
TCT DRAFT

25. Choose Your Partner

26. Know Who Is The Boss

27. And if things are breaking bad…

28. Have Someone to Save You

29. Yes, We Can Do it Together!