
Lead Clinical Research Associate-RN
St. Jude Children's Research Hospital
- Memphis, TN
- $86,320-154,960 per year
- Permanent
- Full-time
- 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 the 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.
- Bachelor's degree in Nursing required.
- Master's degree preferred.
- 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.
- (LC: RN-TN) Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state.
- (LC: RN-MISS, RN-ARK or RN-KY) Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state.