The World’s Best Stop at Nothing
There’s a reason St. Jude Children’s Research Hospital is consistently ranked on Glassdoor’s “Best Places to Work” list. Actually, there are more than 6,500 reasons. At our world-class pediatric research hospital, every one of our 6,500 professionals shares our commitment to making a difference in the lives of the children we serve. There’s a unique bond when you are part of a team that will stop at nothing to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where all employees, regardless of their role, receive the resources, support, and encouragement to advance and grow their careers.
St. Jude is seeking a Trial Documentation Associate I to join our Clinical Trials Administration team. The Trial Documentation Associate I supports clinical trial activities from study start-up through close out. They support cross-functional teams in study start-up, maintenance, and close-out activities in specified administrative functions, including electronic Trial Master File (eTMF) set-up and maintenance. They serve as a point of contact for study teams/sites regarding regulatory documents, in accordance with the project management and monitoring plans. Proficiency in Trial Master File set-up and maintenance is strongly preferred.

MINIMUM EDUCATION AND/OR TRAINING:

• Bachelor’s degree in relevant area required.

MINIMUM EXPERIENCE:

• Minimum Requirement: Prior experience with clinical research operations preferred.
• Prior experience with clinical research operations preferred
• Prior experience managing flow of clinical trial regulatory documents preferred
• Prior experience in study start-up and site management preferred
• Trial Master File (TMF) set up and maintenance experience preferred
• Working knowledge of ICH/GCP guidelines preferred
• SOCRA or ACRP certifications preferred

• 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.