Sr Clinical Research Operations Coordinator

St. Jude is a world-class institution dedicated to breakthrough research and customized care. This is an exciting and unique opportunity to serve as a senior clinical research coordinator for the Childhood Cancer Survivor Study (CCSS).

The CCSS is one of the largest pediatric cancer survivorship studies in the world and has provided many key findings to improve the lives of current and future survivors. We currently follow over 20,000 participants in the CCSS study. This job exists in a highly visible, highly productive, and fast-paced environment with passionate clinicians and researchers.

The Sr Clinical Research Operations Coordinator is responsible for performing data abstraction, collection, and entry to support clinical research. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.

Job Responsibilities:

List any requirements unique to this position in this department.

• Lead institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
• Provide clinical operations expertise to inform clinical trial operational feasibility and delivery, and development of study recruitment and retention strategies.
• Collaborate with pharmaceutical services, study teams, and external stakeholders to forecast study drug needs and develop study-specific supply chain operational plans.
• Participate in/guide contract drafting, negotiation, administration and renewal; resource/supply management; budget development and management for clinical trials/studies; and financial tracking and follow-up (e.g., reimbursements) for assigned projects.
• Guide engagement between cross-functional teams (e.g., regulatory, finance, biosafety, IS), cross-institutional teams, and external groups (e.g., FDA, NIH) for effective execution of trials/studies.
• Drive stakeholder meetings for assigned trials/studies (e.g., PI meetings, CRO trainings, vendor meetings, collaborative study site meetings).
• Monitor project progress and site performance, communicate regular updates to leadership teams/key stakeholders, and address risks and delays.
• Oversee compliance of assigned projects with regulatory requirements and institutional policies.
• Train and mentor teams around clinical trial conduct and project management/coordination.
• Assist in development of standard operating procedures, and implementation of process improvements where feasible.
• 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:

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• Bachelor’s degree in relevant area required.
• Master’s degree preferred.

Minimum Experience:

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• Minimum Requirement: 5+ years of progressive experience in related area (e.g., study design, clinical project management, research study management).
• Experience Exception: Master’s degree and 3+ years of experience.
• Prior clinical, academic, behavioral, pharmaceutical, biomedical, scientific, or related experience.
• Prior experience in coordinating clinical trials/studies in academic center, hospital, or pharmaceutical industry (as applicable).
• Clinical research background strongly preferred.
• Experience leading complex systems/processes/projects in a technical capacity.
• Experience implementing optimization/innovation of institutional systems/processes related to clinical research studies within area.
• Proven performance in earlier role.

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 $86,320 – $154,960 per year for the role of Sr Clinical Research Operations Coordinator.

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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

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