| Location: New Hanover Regional Medical Center Department: Research Full Time Equivalent: full-time Work Type: 64 to 80 Hours Pay Period Work Schedule: 8HR DAY - Most shifts between 7AM-3PM Exempt from Overtime: Exempt: Yes |
| Summary:
The Study Coordinator has diverse responsibilities in support of clinical research, including soliciting, implementing, and coordinating clinical research projects. The Study Coordinator is accountable for ensuring that research studies are conducted according to the sponsor's requirements, as well as institutional and governmental regulations.
Responsibilities:
1. Works with Principal Investigators (PI) in soliciting research studies.
2. Implements and manages clinical research studies.
3. Provides scholarly assistance to faculty and residents for proposed research; assists with publications.
4. Maintains detailed knowledge of all components of study protocols.
5. Prepares reports for submission to the Institutional Review Board (IRB).
6. Provides the sponsoring organization with required documents, such as completed Case Report Forms (CRFs) and query resolution.
7. Identifies protocol related needs and coordinates procedures with various departments, such as specimen collection and processing and scheduling patient appointments for study related activity.
8. Plans and conducts in-service education for personnel involved in the study.
9. Develops and arranges multimedia advertisements for patient recruitment.
10. Screens potential patients for recruitment.
11. Assesses patient/family educational needs with respect to the purpose and potential risks/benefits of study participation.
12. Assists the PI in obtaining informed consent prior to initiation of any study related procedures.
13. Maintains ongoing communication with the PI to review participant progress/behavior, problems encountered, and Adverse Events (AE).
14. Notifies the sponsor, the Regulatory Coordinator, the IRB (and others, as appropriate) of AEs in accordance with federal regulations.
15. Serves as the central source of information on study activities.
16. Maintains the protocol manuals, investigational drug records, and patient shadow charts in an organized and accurate manner for easy retrieval and audit.
17. Abstracts pertinent data from source documents.
18. Ensures accurate documentation, data collection and record-keeping according to the sponsor's requirements, institutional, and governmental regulations.
19. Completes post participation follow-up on all research participants.
20. Participates in quality improvement activities to ensure compliance with regulatory agencies, department and hospital policies and procedures.
21. Prepares and participates in audits (internal and external); develops corrective action plans as necessary.
22. Serves as a liaison between the investigator, governmental agencies, pharmaceutical companies, funding agencies, study monitors, study participants, system personnel, and review boards (IRB, others). |
