Job Title: Study Coordinator

Reports to: Lead Coordinator directly and Site Manager as needed

General Description:

1. Follow all CCRC SOP’s and the employee handbook; adhere to good clinical practices for research.
2. Be able to perform all duties of Research Assistant and Office Manager.

Resource Allocation

1. Keep Lead Coordinator informed of your workload.
2. If you have any extra time-whether anticipated or unanticipated-on a daily or weekly basis-be prepared to help another coordinator or group.
3. Help research assistant set his/her priorities.
4. Share ideas about increasing CCRC efficiency with Lead Coordinator.

Study Conduction:

1. Have in-depth understanding of “own” protocols.
2. Be prepared to assist when needed with other protocols within your team (“working knowledge”).
3. Ensure that source documents capture all information per protocol.
4. Attend initiation visits.
5. Attend investigators meetings as needed.
6. Ensure drug/supplies arrive in a timely manner prior to and during a study so as not to impede enrollment.
7. Review scheduled screens with recruiter to make sure inclusion/exclusion questions have been addressed prior to screening visit.
8. Ensure potential participant qualifies to consent (meets all inclusion/exclusion criteria prior to consenting).
9. Review all medications and medical history with patients at screening visit and update at all study visits.
10. Screen new subjects.
11. Strictly adhere to study protocol. Report any participant complaints or protocol deviations, errors, or violations to Lead Coordinator and possibly to sponsor and IRB.
12. Communicate with sponsor regarding patient or protocol questions.
13. Dispense study drug per protocol.
14. Maintain CCRC’s as well as sponsor’s drug inventory logs.
15. Respond to data queries promptly.
16. Keep PI informed of lab abnormalities.
17. Meet with monitors.
18. Collect adverse event information from patients.
19. Ensure PI assesses all adverse events and determines causality.
20. Report all SAEs to PI and lead coordinator promptly and collect data for submission to Sponsor and IRB in a timely manner.
21. Submit ongoing regulatory reviews once study is up and running
22. Ensure that research assistant(s) does the following (assist as needed):
    a. Completes CRFs correctly and in a timely manner.
    b. Sets up labs for next day.
    c. Gets all charts and CRFs ready for monitoring visit.
    d. Correctly files in regulatory book.

Recruitment of Studies and Participants:

1. Whenever possible, review CCRC’s internal database to identify study patients before enrollment starts. This prescreening should be done in conjunction with recruiter, database manager, and with input from business manager and Dr. Strout.
2. Communicate with recruiter to meet or exceed recruitment goals; assist recruiter with own studies whenever time permits.
3. Own your studies-enrollment is ultimately your responsibility-come up with creative recruitment ideas.
4. Ensure that the “tracker” is correctly filled out with your study’s current information in all columns when it is circulated.
5. Attend business meetings.
6. Communicate with monitors about upcoming studies that CCRC might be considered for.
7. Utilize investigator meetings as an opportunity to network and learn of possible future study opportunities.