Clinical Trials Assistant (Research Site Coordination, Training Provided)
Ability to work independently in all phases of clinical research: initiation, coordination and close-out.
- Initiation: Complete and submit applications and related documents, review and prepare budgets, prepare documentation for approval of budget and clinical trial agreements
- Coordination: Recruit study participants and verify suitability using inclusion/exclusion criteria, maintain case report forms, regulatory binders and study databases, participate in meetings with study staff, interact closely with principal investigators to ensure enrollment and retention, review quality of data with study monitors, prepare adverse event reports and sponsor, maintain record of payments from sponsor
- Close-Out: Maintain documentation for study participant binders, CRFs and regulatory binder, prepare final report of study and submit to HPB, resolve any adverse events with study participants, return rental equipment or study material to sponsor, prepare for audit if necessary
Assist principal investigator with management of research study
- Organize data and review study results with PI
- Prepare documentation for HPB on study progress
- Prepare annual continuation report, study progress report and obtain renewal of informed consent.
- Submit protocol amendments to the HPB
- Perform study procedures and tasks
- Enter and maintain accurate databases including daily back-up
- Prepare for sponsor-initiated or for-cause audit
Comply with regulatory requirements, hospital policy and good clinical practices
- Serve as a resource for study participants and their families
- Develop and maintain knowledge of current regulatory requirements and policies for relevant agencies (Partners, MGH, FDA, NIH, etc.) through seminars and other training opportunities
Perform study related tasks and procedures
- Order study related supplies
- Maintain study codes
- Obtain patient data from medical records, physicians, etc.
- Schedule study appointments
- Escort patients to appointments
- Provide basic explanation of study
- Administer and evaluate study questionnaires
- Document patient visits and procedures
- Store and ship specimens
- Meet on a weekly basis with supervisor to discuss study related issues, problems and concerns
- Meet on a weekly basis with study PI to review all aspects of study.
- Maintain clear and accurate records (written and electronic).
- Prepare study progress reports.
- Interact with sponsor and regulatory agencies
- Min Degree, preferably in Science / Life Sciences / Public Health / Health Sciences / Pharmacy / Medicine / Nursing or similar from an accredited university
- At least 1-2 years of working experience within clinical research settings (e.g. clinical research associate, study coordinator, or research administrator) is advantageous but not essential
- Knowledge of GCP guidelines and applicable regulations and guidelines of clinical research, or ethical principles relating to human biomedical research
- Able to work independently, as well as part of a team
- Able to work with a high degree of accuracy and attention to detail
- Possess excellent analytical, organisation, communication, and interpersonal skills
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Clinical Trials Assistant - Leon)
Leon Leong De Cong
Recruit Express (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd