Clinical Trial Associate

Clinical Trial Associate Job Description Template

Our company is looking for a Clinical Trial Associate to join our team.

Responsibilities:

  • QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines;
  • Assist COMs with eTMF filing and reconciliation as needed;
  • Generate, finalize and distribute study team agendas and meeting minutes;
  • Track study progress in CTMS including patient enrollment and patient status,
  • Assist with preparation of study related documents and presentations;
  • Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies;
  • Sending out regulatory study start up packets to sites, retrieving completed documents and reviewing for completeness and TMF submission;
  • Any other study related tasks assigned by Clinical Operations Team members;
  • Assist COMs with drug and ancillary supply management;
  • Participates in the creation and distribution of study materials, including essential documents, presentations, and reports;
  • Coordinate activities related to Regulatory Inspection – (Prep, retrieval of documents and other “back-room” activities and support);
  • This position reports directly to the Manager, Trial Master File;
  • Assists with the tracking and documenting of site and sponsor training (Study specific, drug and program level);
  • This is a non-supervisory position;
  • Provide clerical support and administrative functions for the Clinical Operations team with heavier focus on study start-up activities.

Requirements:

  • At least 3-5 years experience as CTA (or comparable operating experience) in pharmaceutical, or CRO required;
  • Good listener / problem solver Ability to prioritize and multi-task and demonstrate flexibility and attention to detail;
  • Completed BA/BS in directly-relevant discipline or equivalent experience required.