Senior Clinical Research Associate RN - Department of Infectious Diseases

The Senior Clinical Research Associate‑RN 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.

We are seeking a highly motivated and experienced Senior Clinical Research Associate‑RN to support a growing portfolio of clinical research studies in the Department of Infectious Diseases. This role is critical to ensuring the successful start‑up, execution, and ongoing management of multiple investigator‑initiated and collaborative trials.

The ideal candidate will bring strong project management capabilities, clinical research experience, and the ability to work across multidisciplinary teams. This position offers the opportunity to play a key leadership role in advancing innovative research initiatives that impact patient care and outcomes.

This position will work primarily on campus.

• Lead and manage study start‑up activities for multiple clinical trials, including regulatory coordination, site activation, and operational planning.
• Oversee and support enrollment‑based studies across multiple principal investigators, including studies conducted at partner institutions.
• Coordinate day‑to‑day study operations to ensure timelines, milestones, and compliance requirements are met.
• Serve as a central point of contact for study teams, sponsors, and collaborators.
• Provide hands‑on clinical research support as needed, including serving as a research nurse and assisting with study visits.
• Ensure appropriate staffing and coverage for study visits, including those requiring multiple research nurses.
• Mentor and provide oversight to research nursing staff, supporting their development in both clinical and project management competencies.
• Collaborate with data management, quality assurance, and regulatory teams to ensure high‑quality study execution.
• Support both pre‑activation and post‑activation phases of clinical trials, including studies recruiting from community‑based settings.

• Support project management (lead/monitor planning and delivery) for institutional as well as St. Jude sponsored, multi‑center trials, including regulatory, financial, and administrative aspects of the study.
• Act as site study coordinator for complex, large multi‑site and/or multidisciplinary clinical trials.
• Maintain and share essential study documents (e.g., investigator files, case report forms) as required.
• Assist with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g., CPSRMC and IRB) as applicable.
• Assist in the development of ongoing review of departmental/divisional standard operating procedures and ensure compliance in execution of assigned tasks.
• Oversee quality of data abstraction, collection, and entry to support clinical research of study team members.
• (As applicable) Provide patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).
• 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: 4+ years of experience in carrying out research preferably in healthcare settings.
• Experience Exception:
  Master's degree and 2+ years of experience.
• Experience managing cross‑functional communication, including liaison between site and study teams.
• Experience with documentation and tracking systems/processes.
• Proven performance in earlier role.

• Several years of clinical research experience, with demonstrated involvement in study start‑up and trial management.
• Strong project management and organizational skills, with the ability to manage multiple studies…