Clinical Trial Associate

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

The primary responsibility of the Clinical Trial Associate (CTA) is to assist the Clinical Trial Manager as required to ensure study planning through completion. The CTA will work with CRAs to gather the regulatory documents from clinical sites and work with the study team to ensure completeness of all Trial Master Files (TMF) and any other additional tasks as required. The CTA is the primary file holder for assigned studies.

The CTA will:

• under the direction of the CTM, file all clinical trial documentation in (e)TMF and paper TMF, as assigned. Schedule, prepare and take-minutes for the study team meetings.
• work directly with the study/CRA team and sites to collect documents and maintain the files.
• prepare Investigational Site Folders (ISF) for study-start-up.
• work with study vendors and schedules meetings as required.
• prepare and handle study supply materials and ships to sites.
• run study procedure reports, as required (i.e. EDC, study supply, IRT etc.).
• maintain the study’s (e)TMF and makes requests for outstanding documents as needed.
• periodically review the TMF for completeness.
• complete the (e)TMF study file checklist for each study prior to close-out to assist the study team in updating the files.
• prepare the files for audits (internal and external), as required.
• ensure that training and applicable Sponsor information and/or materials are completed for their position.
• assist in maintaining training files for study team, as needed.
• assist in site payment activities, as required.
• complete any other administrative tasks, as required.
• complete any other task as assigned by direct manager.

The CTA will have:

• working knowledge of clinical drug development and clinical operations processes and experience applying GCP, ICH and FDA requirements.
• strong communication and organizational skills.
• strong motivational skills.
• the ability to perform issue escalation.
• flexibility and be able to work with deadlines.
• the ability to operate independently as well as be a Team Player.
• A solution-oriented and problem-solving attitude.

The CTA will have:

• a College degree, preferentially in sciences/medical sciences.
• 5+ years of experience pharmaceutical industry or clinical research site-based experience.
• proficiency in Microsoft office (i.e. Word, Excel, PPT, Email) and Audio/Video conferencing tools (i.e. WebEx, Zoom).
• knowledge of Regulatory and ICH GCP guidelines.
• system experience preferably in CTMS, eDC, (e)TMF platforms.