Clinical Research Coordinator

Statement of Purpose

To facilitate clinical research activities in the hospital

MAJOR DUTIES AND RESPONSIBILITIES

1. Liaison person with Principle 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 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 laboratory or store specimens in accordance with requirement of research protocol
10. Assist in the completion and maintenance of biological specimen logs
11. Tracing and returning of 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. Documentation of patient reimbursement logs
16. Filing and documentation of paper and electronic case report forms
17. Maintain investigator files and source documentation for each patient accordance to protocol requirements.
18. Identify, document and submit protocol deviations to Institutional Review Board (IRB) according to hospital and sponsor procedures
19. Inform PIs, Co-Investigators, collaborators and study team members on any adjustments based on protocol change
20. Complete, report and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events
21. Traveling to research participants’ house may be required

Leadership

Mentor junior clinical research staff

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)

General 

1. To participate in projects and activities as assigned by Director, Clinical Research Unit

EDUCATION, TRAINING AND EXPERIENCE

1. Degree in health sciences, nursing, pharmacy, clinical research or related field
2. Minimum Diploma or specialized diploma in the above fields