Clinical Research Associate I

San Diego, CA or Remote (U.S.)

  • We are seeking a responsible, dynamic, creative and highly motivated Clinical Research Associate (CRA) to join our Clinical Operations Department. 
  • The Clinical Research Associate (CRA) participates in the planning, coordination, and monitoring activities of clinical trials in the Clinical Operations Department.
  • The CRA provides project support in the initiation, execution and close out of assigned clinical studies. 
  • This is a full-time position in the company’s San Diego headquarters or remote (U.S.).

Specific Responsibilities

  • Provides support as assigned to clinical for clinical trials, including preparation and management of administrative and regulatory documents, and preparation for monitoring visits.
  • Completes word processing, spreadsheet and database assignments, including, but not limited to, correspondence, records, reports, scanning, emailing, copying, filing and other tasks as directed by supervisor. These are done neatly, accurately and in a timely manner.
  • Creates and Manages Investigator Site File and assures that all documents within the file are complete.
  • Manages invoices, payments, and tracking of protocol specific spending.
  • Creates and maintains contact lists and supportive documents for clinical team and for vendors.
  • Tracks protocol changes for amendments.
  • Maintains Frequently Asked Questions log for the study.
  • Manages non-clinical supply and resupply to sites (e.g., Study Manuals, Binders, examination gloves).
  • Complies with institutional and departmental policies and procedures.
  • Drafts CRA Team Meeting agendas and minutes.
  • Shadows CRAs on site visits.
  • Independently monitors 2-3 sites.
  • Performs related duties as assigned by supervisor.
  • Maintains compliance with all company policies and procedures.
  • Assist with vendor management and review of specifications.

Requirements

  • 4 year life sciences or health care related degree.
  • Minimum 2 years of experience independent monitoring. 
  • Proficient in MS Office software.
  • Excellent verbal and written communication skills.
  • Proven ability to collaborate in a team environment and work independently.
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.