Clinical Research Coordinator - #1092576

• 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