Clinical Trial Associate Job Description Template
Our company is looking for a Clinical Trial Associate to join our team.
- 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.
- 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.