Study Coordinator

4 days ago

Klang, Selangor, Malaysia Sunway Medical Centre Full time

Job Summary

This role is responsible to assist the investigator in clinical trial project planning and ensure that pre-established work scope, study protocol, and regulatory requirements are followed. Also, responsible for all elements of the administration and oversight of clinical trial protocols. In addition, recruits and coordinates research subjects, as appropriate, and serves as a principal administrative liaison for the assigned clinical trials.

Key Accountabilities

Clinical Function

  • Ensure the smooth and efficient day-to-day operation of clinical trials, schedule participants' visits as per protocol requirements and manage unscheduled visits of participants and data collection activities; act as the primary administrative point of contact for internal research staff and liaison for other research organizations, funding agencies and regulatory bodies.
  • Recruit, screen, instruct, and coordinate research subjects and/or volunteers.
  • Assess the patient's condition and report any significant variations from baseline measurements to the Principal Investigator.
  • Perform, if applicable, biospecimen collection and processing, receive, dispense, and be accountable for the Investigational Products (IPs).

Administrative Function

  • Plan and coordinate the initiation of trial study protocol, and attend the required training before site initiation.
  • Monitor the progress of trial activities; communicate to the team and site staff on the schedule/required procedures for the visits.
  • Develop and maintain records of trial activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, and/or regulatory bodies.
  • Plan, implement, and maintain data collection and analysis systems according to the clinical trial protocol.
  • Manage and coordinate feasibility studies received from sponsor/CRO, meeting new and potential investigators interested in feasibility questionnaires within the specified deadline.
  • Assist with dispensing participants' travel reimbursement and managing trial-related charge forms, as appropriate to specific study objectives and work scope.
  • Update the CRC team on the progress of the study and keep the team in the loop on communication with the Sponsor/CRO/Investigator.
  • Coordinate with sponsor in project close-out activities including disposal of IPs, and collecting materials for archiving.
  • Involve in and contribute to all quality improvement activities of the department.
  • Maintain essential study documents/files; keep an ongoing recording and assessment of adverse events (AEs), serious adverse events (SAEs), and concomitant medications (CONMEDs); assist with the preparation of reports of SAEs and submission of reports to the relevant ethics committee and manage Case Report Form (CRF) or electronic CRF (eCRF) entries.
  • Notify sponsors and the Ethics Committee of serious adverse events (SAEs) and protocol deviations (PDs).
  • Act as liaison between investigators and CRAs, preparing the site for monitoring, audit, and inspection and subsequent implementation of recommended corrective actions as appropriate.

Job Requirements

  • Degree in Nursing, Biomedical Sciences, or Pharmacy. MBBS/MD with clinical experience will also be considered.
  • Candidates with clinical pharmacy background and experience are preferred.
  • At least 2 years of relevant working experience in clinical research and trial.
  • GCP Certification.

Required Skills

  • Proficient in Microsoft Office.
  • Excellent verbal and written communication skills.
  • Project management experience with strong presentation, organization and networking skills.
  • Strategic thinking and problem solving.
  • Result-driven and goal-oriented attitude.
  • Highly motivated and adaptable in a fast-paced and agile environment.
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