Clinical Trial Associate

About the role

The Clinical Trial Associate (CTA) assists the Clinical Trial Manager to ensure study planning through completion. The CTA works with CRAs to gather regulatory documents from clinical sites and ensures completeness of all Trial Master Files (TMF) and other assigned tasks. The CTA is the primary file holder for assigned studies.

Responsibilities

• Under the direction of the CTM, file all clinical trial documentation in (e)TMF and paper TMF.
• Schedule, prepare, and take minutes for study team meetings.
• Work directly with the study/CRA team and sites to collect documents and maintain files.
• Prepare Investigational Site Folders (ISF) for study start-up.
• Work with study vendors and schedule meetings as required.
• Prepare and handle study supply materials and ship to sites.
• Run study procedure reports (e.g., EDC, study supply, IRT).
• Maintain the study’s (e)TMF and request outstanding documents as needed.
• Periodically review the TMF for completeness.
• Complete the (e)TMF study file checklist for each study prior to close-out.
• Prepare files for audits (internal and external).
• Ensure training and applicable sponsor information/materials are completed for the position.
• Assist in maintaining training files for the study team.
• Assist in site payment activities.
• Complete other administrative tasks as required.
• Complete any other task assigned by the direct manager.

Requirements

• Working knowledge of clinical drug development and clinical operations processes.
• Experience applying GCP, ICH, and FDA requirements.
• Strong communication and organizational skills.
• Strong motivational skills.
• Ability to perform issue escalation.
• Flexibility and ability to work with deadlines.
• Ability to operate independently as well as be a team player.
• Solution-oriented and problem-solving attitude.

Qualifications

• College degree, preferentially in sciences/medical sciences.
• 5+ years of experience in the pharmaceutical industry or clinical research site-based experience.
• Proficiency in Microsoft Office (Word, Excel, PPT, Email) and audio/video conferencing tools (WebEx, Zoom).
• Knowledge of Regulatory and ICH GCP guidelines.
• System experience preferably in CTMS, eDC, and (e)TMF platforms.