About this role
• 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
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