[Hiring] Trial Documentation Associate I @St. Jude Children's Research Hospital

Role Description

St. Jude Children’s Research Hospital is seeking a Trial Documentation Associate I to join their Clinical Trials Administration department. The Trial Documentation Associate I supports clinical trial operations by serving as the regulatory document specialist for study start-up, maintenance, and close-out activities. This role is responsible for:

• Collecting, reviewing, organizing, and maintaining clinical trial documentation in compliance with applicable federal regulations, ICH GCP guidelines, IRB requirements, project plans, SOPs, and institutional guidelines.
• Supporting the Project Manager, Line Manager, and Clinical Trial Operations leadership through the management and maintenance of regulatory documentation, including electronic Trial Master File setup and oversight.
• Coordinating regulatory start-up activities and facilitating the collection of essential documents required for site initiation.
• Serving as a primary point of contact for regulatory documentation inquiries.
• Maintaining ongoing communication with study personnel and participating sites to ensure regulatory files remain complete, current, and inspection-ready within the eTMF.
• Demonstrating professionalism, attention to detail, and discretion while maintaining confidentiality in all interactions with internal and external stakeholders.

This position is remote within approved U.S. locations. Due to state-specific employment regulations, we are unable to consider applicants currently residing in California for remote work; however, candidates based in California who are willing to relocate to an approved location may be considered.

The Trial Documentation Associate I serves as a key resource for regulatory documentation activities and eTMF management, with a primary focus on:

• Collecting, organizing, and maintaining essential regulatory documents.
• Ensuring documentation remains accurate, complete, and inspection-ready throughout the clinical trial lifecycle.

Qualifications

• Bachelor's degree in relevant area required.

Requirements

• Prior experience with clinical research operations preferred.
• Proficiency in Trial Master File (TMF/eTMF) setup and maintenance strongly preferred.
• Working knowledge of ICH/GCP guidelines preferred.
• Prior experience managing flow of clinical trial regulatory documents preferred.
• Prior experience in study start-up and site management preferred.

Benefits

• A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Trial Documentation Associate I.

Company Description

St. Jude is an Equal Opportunity Employer.

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