Clinical Research Co-ordinator
MAJOR DUTIES AND RESPONSIBILITIES
(A) SPECIFIC (90%
1. Liaison person with Principal Investigator (PI), site-PI and various departments for clinical research procedures e.g. Specialist Clinics, Laboratory, wards, etc.
2. Plan, organise and coordinate the workflow of the research study
3. Adhere to protocol procedure
4. Screen research participants for eligibility according to research protocol
5. Enrol research participants and ensure their compliance to research procedures
6. Explain protocol to research participants and ensure that informed consent is taken as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and Human Biomedical Research Act (HBRA) requirements
7. Schedule appointments for research participants within the time frame required in the protocol
8. Arrange for clinical/ laboratory tests and investigations; update schedule visit logs
9. Draw, centrifuge blood specimens and send specimens to laboratory or store specimens in accordance with requirement of research protocol
10. Assist in the completion and maintenance of biological specimen logs
11. Trace and return of case notes, blood results and all other results required in the protocol.
12. Assess subject’s condition; coordinate physical examinations per protocol; record medical drug history according to protocol
13. Collect and maintain data, as well as provide study reports
14. Maintain documentation of patient reimbursement logs, hardcopy and electronic case report forms
15. Maintain investigator files and source documentation for each patient accordance to protocol requirements.
16. Identify, document and submit protocol deviations to Institutional Review Board (IRB) according to research requirements
17. Inform PIs, Co-Investigators, collaborators and study team members on any adjustments based on protocol change
18. Complete, report and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events
19. Traveling to research participants’ house may be required
20. Work closely with SOC clinical staff (e.g. physicians, PSAs) in clinical decision support, therapeutic interventions, and first-visit interventions.
Leadership
Mentor junior clinical research staff
Others
1. Perform quality checks on studies as Institution Monitor (where applicable)
2. Be a NHG Committee of Practice (CoP) or Faculty member in CRC Society (where applicable)
(B) GENERAL (10%)
- Participate in projects and activities as assigned by the Team Lead or Director, Clinical Research Unit