Clinical Research Coordinator

Job Responsibilities

• Liaison person with Principal 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

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.