Documentation Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the setup, maintenance, and closeout of the electronic Trial Master File (eTMF) in line with WEP Clinical protocols, sponsor requirements, and relevant regulations.

• Work collaboratively with internal project teams to ensure prompt retrieval, filing, and accessibility of critical documents.

• Manage systems and tools utilized for the evaluation, tracking, and transmission of TMF documents.

• Perform thorough quality checks and content reviews of eTMF documents, including necessary paper originals.

• Create and supply TMF metrics and content reports to project management teams and leadership.

• Scan or coordinate the scanning, labeling, uploading, and proper filing of documents for traceability and accessibility.

• Ensure compliance with privacy, security, and document retention standards.

• Assist in TMF archival processes and develop long-term document storage strategies following project completion.

• Support both internal and external TMF audits to ensure compliance with SOPs, policies, FDA, and ICH GCP guidelines.

• Keep study status trackers and other project documentation tools up to date.

• Label, sort, categorize, and retrieve documents as necessary.

• Aid in training staff on proper documentation practices.

• Carry out proofreading and administrative tasks as required.

⛳️ Requirements

• A bachelor’s degree is preferred.

• 1–2 years of experience in order processing and documentation management systems is preferred.

• Familiarity with clinical study documentation, including quality control, SOPs, GCP guidelines, and best practices for archiving.

• Experience with electronic databases for clinical trials is preferred.

• Demonstrated ability to meet quality and timeline objectives.

• Strong computer skills, particularly proficiency in Microsoft Office.

• Expertise in formatting and publishing documents, as well as maintaining tracking systems.

• Capable of coordinating document reviews and finalization across multiple stakeholders.

• Quick adaptability to new software programs and databases.

• Ability to remain in a stationary position for extended periods as part of normal daily activities, with reasonable accommodations considered where appropriate.

• Candidates must reside in a U.S. state where the company is authorized to hire.

• This position is not available to residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia.

• Resumes must be submitted in English.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Flexible Spending Account (FSA), Health Savings Account (HSA).

• Optional Critical Illness, Hospital Indemnity, and Accident Insurance.

• Group short-term and long-term disability insurance.

• Group Life Insurance.

• 401K safe harbor plan with company matching.

• Paid vacation, holidays, sick leave, and volunteer time.

• Paid maternity and paternity leave.

• Initiatives for wellness, growth and development, and team relationship building.

• Team events.

• An inclusive and supportive work environment.

• Reasonable accommodations for qualified individuals with known disabilities.

• A smoke-free, drug-free, and alcohol-free workplace.