Trial Documentation Associate I

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

📋 Description

• Assist in clinical trial operations as the regulatory document specialist throughout study start-up, maintenance, and close-out phases.

• Gather, assess, organize, and manage clinical trial documentation efficiently.

• Establish and supervise electronic Trial Master Files (eTMF).

• Aid the Project Manager, Line Manager, and Clinical Trial Operations leadership in managing regulatory documents.

• Coordinate regulatory start-up tasks and facilitate the collection of essential documents necessary for site initiation.

• Act as the primary contact for inquiries related to regulatory documentation.

• Maintain communication with study personnel and participating sites to ensure that regulatory files are complete, up-to-date, and ready for inspection.

• Provide continuous support for clinical research operations, including the maintenance of study documentation and monitoring reports.

• Activate new and amended protocols at the institutional level.

• Track documentation, study status, and key milestones using CTMS, eTMF, and other systems.

• Communicate effectively with study and monitoring teams, sponsors, and site teams.

• Monitor case report forms for low-risk studies as necessary.

• Ensure adherence to study procedures and conventions.

• Perform additional duties as assigned to achieve departmental and institutional objectives.

• Maintain consistent and predictable attendance.

⛳️ Requirements

• A Bachelor's degree in a relevant field is required.

• Previous experience in clinical research operations is preferred.

• Strong preference for proficiency in Trial Master File (TMF/eTMF) setup and maintenance.

• A working knowledge of ICH/GCP guidelines is preferred.

• Prior experience in managing the flow of clinical trial regulatory documents is preferred.

• Experience in study start-up and site management is preferred.

• Must reside in an approved U.S. location for remote work.

• Applicants currently living in California are ineligible for remote work unless they are willing to relocate to an approved location.

• Ability to maintain consistent and predictable attendance.

• Display professionalism, attention to detail, discretion, and confidentiality in interactions with both internal and external stakeholders.

🏝️ Benefits

• Remote work opportunities within approved U.S. locations.

• Annual salary range of $65,520–$114,400.

• Exceptional benefits (details not specified in the posting).

• Equal Opportunity Employer.