Clinical Research Coordinator (Contract)

Responsibilities:

You will assist the principal investigators in development and implementation of clinical research and clinical trial protocol including:

• Preparation of documents for and facilitation of regulatory (e.g. Institution Review Board, Health Sciences Authority) approvals
• Design and develop informed consent form, data collection forms, logs and other study related documents.
• Purchase and maintain inventory checks on research supplies for assigned studies.
• Execution of approved clinical research and clinical trial protocols in accordance to the ICH-Guideline for Good Clinical Practice (ICH-GCP), Human Biomedical Research Act (HBRA) and other regulatory requirements, including (but not limited to) assisting the principal investigator(s) in:
  • contacting and handling queries by research subjects
  • research subject’s consent taking
  • scheduling clinic appointments for research subjects
  • completing data collection forms
  • setting up and entry of research data into the study database
  • administering surveys or questionnaires
  • managing investigational drugs/devices and
  • other patient-fronting research activities stated in the protocol.
• Setting up and maintaining Investigator study files(s), including records of all approvals and reports
• Coordinating and taking notes for study specific meetings between the investigators and their study team members
• Ensure timely preparation and submission of study progress reports
• Preparation for study audits by relevant regulatory authorities
• Conduct periodical inventory check on all investigational items.

As part of the ACP Office (Research), you will provide administrative support for research initiatives whenever the Office requires. You will also require to be part of certain workgroups or organizing committee which your Office has nominated you for.

Requirements:

• Preferably degree in Nursing, Biological Science, Pharmacy or other healthcare related discipline

• Familiar with ICH-Guideline for Good Clinical Practice (ICH-GCP), research ethics and regulatory requirements for conducting clinical research

• Familiar with usage of Microsoft Office, particularly Powerpoint, Word and Excel

• Excellent interpersonal and communication skills