Clinical Research Associate Job at CEDENT, Los Angeles, CA

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  • CEDENT
  • Los Angeles, CA

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,

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