Job Description
Summary: The Clinical Research Associate (CRA) is responsible for managing and maintaining the Study Master File, tracking essential trial information, and supporting Regional Clinical Research Associates. Working under the guidance of a Clinical Manager or Director, the CRA ensures accurate documentation, regulatory compliance, and efficient coordination of trial logistics.
Key Responsibilities: - Set up and maintain the Study Master File and Study Master File Tracker for each study.
- Receive, quality check, scan, and file study documents in the Study Master File; provide status updates to Clinical Management.
- Collect site start-up documents by directly communicating with site staff, preparing Regulatory Binders, and filing documents in the Study Master File.
- Track critical trial information, including team and site contact details, site status, enrollment, adverse events, and payments.
- Participate in clinical team meetings, assist with meeting logistics, and prepare materials and minutes as needed.
- Coordinate shipments of investigational products (IP) and other materials to trial sites.
Qualifications: - Experience in ophthalmology and familiarity with clinical trial documentation.
- Strong data entry, problem-solving, and analytical skills.
- Proficiency in written and verbal communication, with presentation skills.
- Ability to work independently and collaboratively within a team.
- Excellent organizational skills and attention to detail.
- Knowledge of medical and ophthalmology terminology is helpful.
- Experience in study monitoring and auditing, with willingness to travel up to 75%.
Job Tags
Full time,