Trial Documentation Associate I

The World’s Best Stop at Nothing

There’s a reason St. Jude Children’s Research Hospital is consistently ranked on Fortune Magazine’s “100 Best Places to Work For” list. Actually, there are more than 3,600 reasons. At our world-class pediatric research hospital, every one of our 3,600+ professionals shares our commitment to making a difference in the lives of the children we serve. There’s a unique bond when you’re 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.

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.

• 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

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!

Diversity, Equity and Inclusion

St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay. Learn more about our history and commitment.

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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.

Apply