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Documentation Specialist
WEP Clinical. Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with WEP Clinical processes, sponsor requirements, and applicable regulations .
About the role
Key responsibilities & impact- 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 and content reviews of eTMF documents, including required paper originals
- Generate and provide TMF metrics and content reports to project management teams and leadership
- Scan or coordinate scanning, label, upload, and appropriately file documents for traceability and accessibility
- Ensure adherence to privacy, security, and document retention standards
- Support TMF archival activities and long-term document storage strategies after project closeout
- Assist with internal and external TMF audits for 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
- Perform proofreading and administrative tasks as needed
Requirements
What you’ll need- 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
- Candidates must reside in a U.S. state where the company is authorized to hire
- This role is not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia
- Resume must be submitted in English
Benefits
Comp & perks- 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
- Wellness, growth and development, and team relationship initiatives
- Team events
- Inclusive, supportive work environment
- Reasonable accommodations for qualified individuals with known disabilities
- Smoke-free, drug-free, and alcohol-free work environment