Documentation Specialist

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

The WEP Clinical Documentation Specialist is responsible for supporting the management of program documentation in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and project specific Trial Master File (TMF) plans.

• Detail-oriented
• Highly Organized
• Adaptable
• Team Player

• Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with WEP Clinical processes, sponsor requirements, and applicable regulations.
• Collaborate with internal project teams to ensure timely retrieval, filing, and availability of essential documents.
• Maintain systems and tools used to evaluate, track, and transmit TMF documents.
• Conduct detailed quality checks (QC) and content reviews of eTMF documents at defined time points, including any required paper originals.
• Generate and provide TMF metrics and content reports to project management teams and leadership, as assigned.
• Scan (or coordinate scanning), label, upload, and appropriately file documents to ensure traceability and accessibility.
• Ensure adherence to WEP Clinical privacy, security, and document retention standards.
• Support TMF archival activities and long-term document storage strategies following project closeout.
• Assist with internal and external TMF audits to ensure compliance with SOPs, policies, FDA, and ICH GCP guidelines.
• Maintain study status trackers and other project documentation tools.
• Label, sort, categorize, and retrieve documents; assist with training staff on documentation practices and perform proofreading and administrative tasks as needed.

• Bachelor’s degree preferred
• 1 - 2 years of experience in order processing and documentation management systems preferred
• Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices
• Experience with clinical trial electronic databases preferred
• Proven ability to meet quality and timeline objectives
• Strong computer skills, including proficiency in Microsoft Office
• Skilled in formatting and publishing documents, and maintaining tracking systems
• Able to coordinate document review and finalization across multiple stakeholders
• Quick to learn new software programs and databases
• Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+…