[Hiring] Documentation Specialist @WEP Clinical

Role Description

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.

Role Objectives

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
• Project-specific Trial Master File (TMF) plans

The Ideal Candidate:

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

What You'll Do:

• 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.

Qualifications

• 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

Benefits

• 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