Job Description

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.

• 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.

• 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%.

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