Clinical Research Co-ordinator

Khoo Teck Puat Hospital; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Khoo Teck Puat Hospital is seeking a Clinical Research Coordinator to liaison with the PI, site-PI and multiple departments, planning and coordinating the workflow of the study while ensuring protocol adherence in line with ICH-GCP and HBRA standards.

You will screen and enrol participants, obtain informed consent, schedule visits and tests, collect and maintain data, and support regulatory submissions, logs and reports. Travel to participant homes may be required.

Qualifications

• Evidence of relevant degree or diploma in health sciences or clinical research.
• Experience in conducting clinical trials or research is required.
• Familiarity with clinical research regulations and ethics frameworks.

Responsibilities

• Liaise with PI, site-PI and departments for clinical research procedures.
• Plan, organise and coordinate the workflow of the research study.
• Screen participants for eligibility according to protocol.
• Enrol participants and ensure compliance with procedures.
• Explain protocol and obtain informed consent per ICH-GCP and HBRA.
• Schedule appointments within protocol timeframes and coordinate tests.
• Maintain data and documentation, including case report forms and logs.
• Submit protocol deviations to IRB and report adverse events.
• Travel to participants' homes as required.

Education

Degree in health sciences, nursing, pharmacy, clinical research or related field

Diploma or specialized diploma in the above

At least 3 years of experience in conducting clinical trials or research

Job description

Company description:

Khoo Teck Puat Hospital

Job description:

• 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