Sr Clinical Research Operations Coordinator

at  St Jude Childrens Research Hospital

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.

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.

STATE THE MINIMUM EDUCATION AND/OR TRAINING REQUIRED.

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

STATE THE MINIMUM YEARS OF EXPERIENCE REQUIRED TO DO THIS JOB SUCCESSFULLY.

• 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.