Job Description

MAJOR DUTIES AND 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

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 fields

Institution

Khoo Teck Puat Hospital (KTPH)

Job Family

Allied Health

Working Hours

Office Hours

Education Level

Bachelor Degree

Job Level

Junior Executive

Employment Type

Contract Full-Time