- Liaison person with Principle Investigator (PI), site-PI and various departments for clinical research procedures e.g. Specialist Clinics, Laboratory, wards, etc.
- Plan, organise and coordinate the workflow of the research study
- Adhere to protocol procedure
- Screen research participants for eligibility according to research protocol
- Enrol research participants and ensure their compliance to research procedures
- 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
- Schedule appointments for research participants within the time frame required in the protocol
- Arrange for clinical/ laboratory tests and investigations; update schedule visit logs
- Draw, centrifuge blood specimens and send specimens to laboratory or store specimens in accordance with requirement of research protocol
- Assist in the completion and maintenance of biological specimen logs
- Tracing and returning of case notes, blood results and all other results required in the protocol.
- Assist with the completion and maintenance of investigational product receipt, storage, accountability, dispensing and disposal records
- Assess subject’s condition; coordinate physical examinations per protocol; record medical drug history according to protocol
- Collect and maintain data, as well as provide study reports
- Documentation of patient reimbursement logs
Filing and documentation of paper and electronic case report forms - Maintain investigator files and source documentation for each patient accordance to protocol requirements.
- Identify, document and submit protocol deviations to Institutional Review Board (IRB) according to hospital and sponsor procedures
- Inform PIs, Co-Investigators, collaborators and study team members on any adjustments based on protocol change
- Complete, report and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events
- Traveling to research participants’ house may be required
Others
- Perform quality checks on studies as Institution Monitor (where applicable)
- NHG Committee of Practice (CoP) or Faculty member in CRC Society (where applicable)
JOB REQUIREMENTS
(A) EDUCATION, TRAINING AND EXPERIENCE
- Degree in health sciences, nursing, pharmacy, clinical research or related field
- Minimum Diploma or specialized diploma in the above
- At least 3 years of experience in conducting clinical trials or research
