Summary:

The Clinical Trial Associate (CTA) of Development Operations plays a vital role in supporting the execution of clinical trials by assisting study teams, tracking biospecimens, and ensuring eTMF inspection readiness. Reporting to the Clinical Trial Manager and SVP of Development Operations, the CTA manages key administrative and operational activities to maintain trial compliance and organization.
 

Key Responsibilities:

  • Proactively review internal and external eTMFs, perform spot checks, and address inconsistencies for inspection readiness.

  • Prepare for audits and inspections.

  • Coordinate logistics for internal and external meetings, prepare agendas, and document meeting minutes.

  • Update Clinical Trial Governance on clinicaltrials.gov.

  • Maintain staff and vendor lists.

  • Collaborate with the Clinical Trial Manager on Trial Master Data reviews.

  • Contribute to Trial Oversight and TMF plans.

  • Take a lead role in managing clinical biospecimen inventory and tracking.

  • Assist with site contracts, trial dashboard updates, and trial budget maintenance.

  • Support the filing of appendices for the Clinical Study Report (CSR).

  • Prepare for inspections.
     

Qualifications:

  • B.A./B.S. in life sciences or related field.

  • Minimum of 2 years of clinical research experience, preferably in the pharmaceutical or biotech industry.

  • Knowledge of FDA/ICH guidelines and GCP standards; familiarity with CTMS, EDC, TMS preferred.

  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).

  • Strong organizational skills, attention to detail, and ability to manage multiple priorities in a dynamic environment.

  • Excellent communication and interpersonal skills, with a collaborative approach and ability to motivate teams.

Department: Direct Clients
This is a full time position

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