Clinical Research Coordinator

Responsibilities:

1. Liaison person with Principal Investigator (PI), site-PI, and various departments for clinical research procedures (e.g., Specialist Clinics, Laboratory, wards).
2. Plan, organize, and coordinate the workflow of the research study.
3. Adhere to protocol procedures.
4. Screen research participants for eligibility according to research protocol.
5. Enroll research participants and ensure their compliance with research procedures.
6. Explain the protocol to research participants and ensure that informed consent is taken as per International Council of Harmonisation Clinical Practice (ICH-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 the laboratory or store specimens in accordance with the requirements of the research protocol.
10. Assist in the completion and maintenance of biological specimen logs.
11. Trace and return case notes, blood results, and all other results required in the protocol.
12. Assist with the completion and maintenance of investigational product receipt, storage, accountability, dispensing, and disposal records.
13. Assess subject’s condition; coordinate physical examinations per protocol; record medical drug history according to protocol.
14. Collect and maintain data, as well as provide study reports.
15. Document patient reimbursement logs and file documentation of paper and electronic case report forms.
16. Maintain investigator files and source documentation for each patient in accordance with protocol requirements.
17. Identify, document, and submit protocol deviations to the Institutional Review Board (IRB) according to hospital and sponsor procedures.
18. Inform PIs, Co-Investigators, collaborators, and study team members on any adjustments based on protocol changes.
19. Complete, report, and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events.
20. Traveling to research participants’ homes may be required.

Others:

1. Perform quality checks on studies as Institution Monitor (where applicable).
2. NHG Committee of Practice (CoP) or Faculty member in CRC Society (where applicable).

Job Requirements:

1. Degree in health sciences, nursing, pharmacy, clinical research, or related field.
2. Minimum Diploma or specialized diploma in the above.
3. At least 3 years of experience in conducting clinical trials or research.