Overview of Role
The Department of Ophthalmology, is looking for a clinical research coordinator who plays a vital role in supporting and advancing clinical research focused on retinal diseases and therapies. This position is responsible for coordinating and managing retina-related clinical studies from initiation to close-out, ensuring strict adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
Roles and Responsibilities
- Plan, coordinate, and execute clinical research studies from initiation to close-out, ensuring adherence to study protocols and timelines.
- Screen, recruit, and enrol eligible study participants, obtaining informed consent in accordance with ethical and regulatory requirements.
- Collect, manage, and analyze study data in line with protocol requirements and regulatory standards, ensuring data integrity and accuracy.
- Maintain comprehensive and organized study documentation, including regulatory binders, case report forms, and participant records.
- Collaborate with study sponsors, regulatory authorities, and study sites to ensure ongoing compliance and efficient study progress.
- Manage study drug and device inventory, ensuring proper storage, handling, and accountability.
- Monitor and report adverse events, protocol deviations, and other critical issues to study sponsors and regulatory authorities as required.
- Assist in the preparation and submission of study progress reports, regulatory submissions, and ethics applications.
- Ensure full compliance with Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements
- Support the Research Manager in grant planning, budget verification, cost assessments, monthly invoicing, and account management.
- Contribute to department events, ad-hoc projects, and other administrative duties as needed.
- Ensure timely follow-up and completion of all assigned tasks within stipulated deadlines.
Requirements
- Registered Optometrist with Singapore Optometrists & Opticians Board (OOB).
- Have first degree with good results; preferably with some experience in research.
- Candidates with a basic understanding of statistical analysis are preferred.
- Able to work independently and in a team, have an investigative nature, attention to detail.
- Have knowledge of computer applications, e.g. SPSS, MS office, PowerPoint.
- Prior experience in clinical research or healthcare is advantageous.
- Strong organizational skills and attention to detail.
- Effective communication and interpersonal skills for engaging with study participants, team members, and external collaborators.
- Familiarity with GCP, clinical trial processes, and relevant regulatory standards.
