Clinical Trial Operations Specialist

kps life; Malvern (Chester County); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

kps life is seeking a Clinical Trial Associate (CTA) to support the Clinical Trial Manager in study planning through completion. The CTA will gather regulatory documents from sites, maintain TMF/file integrity, and serve as the primary file holder for assigned studies.

Responsibilities include filing in (e)TMF and paper TMF, preparing ISFs, coordinating with vendors, running trial reports, and assisting in audits and training.

Qualifikationen

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

Aufgaben

• File all clinical trial documentation in (e)TMF and paper TMF; schedule and take minutes for study team meetings.
• Collect documents from sites and maintain the files; prepare ISF for study-start-up.
• Coordinate with study vendors and schedule meetings; manage study supply materials and shipments to sites.
• Run study procedure reports (EDC, study supply, IRT, etc.) and ensure TMF completeness.
• Assist in audits (internal and external), training, and site payment activities; perform other admin tasks as assigned.

Jobbeschreibung

kps life is seeking a Clinical Trial Associate (CTA) to support the Clinical Trial Manager in study planning through completion. The CTA will gather regulatory documents from sites, maintain TMF/file integrity, and serve as the primary file holder for assigned studies.

Responsibilities include filing in (e)TMF and paper TMF, preparing ISFs, coordinating with vendors, running trial reports, and assisting in audits and training.