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Clinical Trial Associate

Sr. Clinical Trial Associate- Cambridge, MA

Job Description:

A pharmaceutical company seeking a highly enthusiastic individual who will have the opportunity to assist project managers in all phases. The Clinical Trial Associate will be responsible for multiple functions of the trial including serving as a point of contact for investigator sites, ensure compliance with protocol and overall clinical objectives, relies on instructions and pre-established SOPs to perform the functions of the job while working under supervision of a supervisor or manager. The Sr. CTA will work under the supervision of a supervisor or manager while performing day-to-day activities under the guidance of the clinical project managers.

Responsibilities:

  • Participate in study start-up, conduct and closeout activities
  • Collects and reviews site regulatory documents for accuracy and completion
  • Assists with preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs)
  • Support project management activities including taking meeting minutes/providing agendas to clinical team, tracking screening/ enrolment across all sites and maintaining study status trackers
  • Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs
  • Maintains the Trial Master File (TMF) for all clinical projects

Qualifications:

  • Bachelor of Science Degree preferred
  • 2+ years of supporting clinical studies at a CRO, pharmaceutical or biotech company
  • Familiarity with the DIA TMF Reference Model desired but not required

If you or a Sr. Clinical Trial Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Agency in relation to this vacancy.