Clinical Research Coordinator
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