Position:

The Clinical Trials Associate will provide support for the creation and maintenance of a paper and or electronic Trial Master Files (TMF) with a focus on maintaining Inspection Readiness throughout the lifecycle of a given Clinical Trial. This role plays an integral part in assuring that assigned TMFs are complete, accurate and timely.

Responsibilities:

• Support the clinical trial manager(s) for all phases of study conduct (feasibility, start-up, maintenance and close-out) of clinical trials.
• Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.).
• Provide regulatory agency inspection support by formatting, proof reading documents and contributing to the review of the Trial Master File.
• Assist clinical trial manager(s) with preparation, handling and distribution of Clinical trial supplies and tracking information.
• Prepare and maintain investigator information tracker for clinical trial operations.
• Assist with clinical trial protocol and clinical study report (CSR) review, and support for documentation requirements for CSR appendices
• Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
• Receipt, review, and filing of documents submitted for the TMF
• Coordinate timely resolution of document issues with the documents Authoritative Sources including Clinical Research Sites, Data Management Centers, Sponsors and other trial collaborators.
• Generate Certified Copies when applicable
• Create Metrics Reports to assist sponsors with trial oversight and demonstrate quality & completeness of the TMF as well as timely submission of TMF documents.
• Review regulatory documents to ensure completeness in accordance with sponsor requirements, ICH/GCPs, FDA Regulations, EMA, MHRA and other health authority regulations.

Qualifications:

• Bachelor’s Degree.
• Minimum 3 years of experience as a CTA in the Pharmaceutical, Biotechnology, or Contract Research Industry.
• Familiarity with CTMF requirements and practices is required.
• Prior experience with creation and maintenance of Trial Master Files and/or Document Management is required.
• Experience with Electronic Data Management Systems (EDMS) and performing in the role of Clinical Research/Trial Associate (field or in-house) or Study Coordinator.
• Demonstrated organization skills and attention to detail.
• Proficient computer skills (e.g. Microsoft Word, Excel, and PowerPoint) required.