Overview
Responsibilities for clinical research coordination and participant-related activities as part of the Clinical Research Unit.
Responsibilities
- Liaison with Principal Investigator (PI) and site-PI, and with various departments for clinical research procedures (e.g., Specialist Clinics, Laboratory, wards).
- Adherence to protocol procedures.
- Screen and recruit suitable candidates as research participants.
- Explain protocol to research participants and ensure informed consent is taken as per ICH-GCP and HBRA requirements.
- Contact and schedule appointments for research subjects within the protocol time frame.
- Centrifige blood specimens and send specimens to the laboratory.
- Trace and return case notes, blood results and all other results required in the protocol.
- Responsible for data collection and performing research procedures.
- Maintain documentation of patient reimbursement logs, hardcopy and electronic case report forms.
- Maintain source documentation for each patient in accordance with protocol requirements.
- Identify, document and submit protocol deviations to the Institutional Review Board (IRB) according to hospital and sponsor procedures.
- Inform PIs and collaborators of adjustments based on protocol changes.
- Complete, report and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events.
- Work with in-house Research Database IT Specialist on extraction of patient medical records and data mining.
- Travel to research participants’ homes may be required.
- Participate in projects and activities as assigned by Director, Clinical Research Unit.
Qualifications
- Minimum Diploma in Biomedical Science or equivalent.
- Experience as a Research Assistant will be preferred.