About the role
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.
The Trial Documentation Associate supports 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. Working closely with study teams and participating sites, the Trial Documentation Associate coordinates regulatory start-up activities, facilitates the collection of essential documents required for site initiation, and serves as a primary point of contact for regulatory documentation inquiries.
The Trial Documentation Associate maintains ongoing communication with study personnel and participating sites to ensure regulatory files remain complete, current, and inspection-ready within the eTMF. This position also demonstrates 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 supports clinical trial activities from study start-up through close out, with a primary focus on regulatory document management and electronic Trial Master File (eTMF) maintenance. This role partners with cross-functional study teams and participating sites to collect, organize, and maintain essential regulatory documents, ensuring documentation remains accurate, complete, and inspection ready throughout the clinical trial lifecycle. The Trial Documentation Associate I serves as a key resource for regulatory documentation activities and eTMF management.
Proficiency in Trial Master File (TMF/eTMF) setup and maintenance is strongly preferred.
Job Responsibilities:
Provide ongoing assistance to support clinical research operations (e.g., study documentation maintenance; monitoring reports).
Collect, review, and maintain essential documents.
Activate new and amended protocols at an institutional level.
Track and update documentation, study status, and key milestones within CTMS, eTMF, and other systems and applications as needed.
Communicate with study and/or monitoring teams as well as study sponsors/site teams as required.
Monitor case report forms for lowest risk studies as needed.
Ensure compliance with procedures/conventions of the assigned studies.
Perform other duties as assigned to meet the goals and objectives of the department and institution.
Maintains regular and predictable attendance.
Minimum Education and/or Training:
Bachelor's degree in relevant area required
Minimum Experience:
Minimum Requirement: 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
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Trial Documentation Associate I.Explore our exceptional benefits!
St. Jude is an Equal Opportunity Employer
No Search Firms
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
Originally posted on Himalayas