Clinical Trials TMF & Documentation Coordinator

Kps-Life; Malvern (Chester County); On-site; USD 65,000 - 90,000; Full time

Job summary

Kps-Life is seeking a Clinical Trial Associate to assist the Clinical Trial Manager and drive study documentation through to completion. The CTA will gather regulatory documents from sites, maintain TMF files, and act as the primary file holder for assigned studies.

Responsibilities include filing documents in eTMF/paper TMF, preparing ISF, coordinating with vendors and sites, and running study reports. Strong GCP knowledge and organizational skills are essential for success in this role.

Qualifications

• College degree in sciences/medical sciences required.
• 5+ years in pharmaceutical industry or clinical research site-based experience.
• Knowledge of regulatory and ICH GCP guidelines.

Responsibilities

• Assist CTM to plan and complete studies; serve as primary TMF/file owner.
• File all clinical trial documents in eTMF and paper TMF; take minutes for study meetings.
• Prepare ISF for start-up and coordinate with vendors and sites.
• Handle study supply materials and shipments; run procedure reports (EDC, IRT).
• Assist with site payments and complete administrative tasks as required.
• Prepare files for audits and ensure training materials are up to date.

Skills

Communication skills

Organizational skills

Problem-solving

Team collaboration

Education

Bachelor's degree in sciences/medical sciences

Tools

Microsoft Office

WebEx/Zoom

CTMS

eDC

(e)TMF platforms

Job description

Kps-Life is seeking a Clinical Trial Associate to assist the Clinical Trial Manager and drive study documentation through to completion. The CTA will gather regulatory documents from sites, maintain TMF files, and act as the primary file holder for assigned studies.

Responsibilities include filing documents in eTMF/paper TMF, preparing ISF, coordinating with vendors and sites, and running study reports. Strong GCP knowledge and organizational skills are essential for success in this role.