Trial Documentation Associate I

🔥 0 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

💵 $65.5k - $114.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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St. Jude Children's Research Hospital

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🤝 Non-profit

Healthcare • Non-profit

St. Jude Children's Research Hospital is a global leader in the research and treatment of pediatric cancer and other life-threatening diseases of childhood. Headquartered in Memphis, Tennessee, it is the first and only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Recognized as one of the world’s premier pediatric research and treatment institutions, St. Jude focuses on conditions like acute lymphoblastic leukemia and brain tumors. The hospital treats about 8,600 children each year and shares research and treatments to improve survival rates for children worldwide through its global initiatives.

📋 Description

• Support clinical trial operations as the regulatory document specialist across study start-up, maintenance, and close-out • Collect, review, organize, and maintain clinical trial documentation • Set up and oversee electronic Trial Master Files (eTMF) • Support the Project Manager, Line Manager, and Clinical Trial Operations leadership through regulatory document management • Coordinate regulatory start-up activities and facilitate collection of essential documents for site initiation • Serve as a primary point of contact for regulatory documentation inquiries • Maintain communication with study personnel and participating sites to keep regulatory files complete, current, and inspection-ready • Provide ongoing assistance for clinical research operations, including study documentation maintenance and monitoring reports • Activate new and amended protocols at an institutional level • Track documentation, study status, and key milestones in CTMS, eTMF, and other systems • Communicate with study and monitoring teams, sponsors, and site teams • Monitor case report forms for lowest-risk studies as needed • Ensure compliance with study procedures and conventions • Perform other duties assigned to meet department and institutional goals • Maintain regular and predictable attendance

🎯 Requirements

• Bachelor's degree in relevant area required • 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 clinical trial regulatory document flow preferred • Prior experience in study start-up and site management preferred • Must reside in an approved U.S. location for remote work • Applicants currently residing in California are not eligible for remote work unless willing to relocate to an approved location • Ability to maintain regular and predictable attendance • Professionalism, attention to detail, discretion, and confidentiality in interactions with internal and external stakeholders

🏖️ Benefits

• Remote work within approved U.S. locations • Salary range of $65,520–$114,400 per year • Exceptional benefits (details not specified in the posting) • Equal Opportunity Employer