Clinical Research Coordinator
Job Summary
The Clinical Research Coordinator acts as the primary liaison between the Principal Investigator and various hospital departments to manage clinical research workflows. This role involves screening and enrolling participants, ensuring adherence to ICH-GCP and HBRA standards throughout the study. Additionally, the coordinator manages study documentation, biological specimens, and adverse event reporting to ensure protocol compliance.
Responsibilities
- Coordinate clinical research workflows and protocols
- Screen and enroll research participants
- Manage biological specimens and laboratory tests
- Maintain regulatory documentation and investigator files
- Report adverse events and protocol deviations
Required Skills
- Degree/Diploma in Health Sciences or related field
- 3+ years clinical trial experience
- Knowledge of ICH-GCP and HBRA
- Data management and documentation
- Clinical specimen handling
Job Details
Responsibilities:
- 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.
- 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:
- 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.