Clinical Research Manager Licensed (RN) - Medicine Clinical Trials Office
Mount Sinai Health SystemAbout the role
The Clinical Research Manager Licensed has oversight of the research projects within a department or division. Assists the Principal Investigator (P.I.) in preparing and negotiating clinical trials care delivery, patient eligibility, budgets, adequate staffing and all related HR activity.
The Clinical Trials Office is seeking a highly skilled Clinical Research Nurse manager to lead and support and support a growing portfolio of cellular therapy clinical research, with primary focus on non-malignant CAR-T and cellular therapy studies, while providing transitional collaboration of malignant Bone Marrow Transplant (BMT)/Cellular Therapy programs.
This role will initially focus on the coordination and implementation of complex clinical research studies involving CAR-T cell therapy and non-malignant cellular therapy (50% effort) and support of malignant Bone Marrow Transplant (BMT/Cellular Therapy) activities for 50% effort. Over time, the non-malignant effort will grow, and the malignant effort will decrease. The role will ensure participant safety, protocol adherence, and regulatory compliance while collaborating with principal investigators and multidisciplinary teams to achieve successful study execution and maintain data integrity.
This role involves direct patient interaction, ensuring the safety and well-being of study participants, adhering to study protocols, and maintaining regulatory compliance. This position is ideal for a highly organized professional who thrives in a fast-paced environment and excels at managing complex workflows, regulatory documentation, and multi-study coordination. Under minimal supervision, the Clinical Research function includes studies of increased complexity. The position features a dual reporting structure to Tisch Cancer Institute and to Departmental Clinical Research teams with and without nursing licensure, requiring strong communication and adaptability. Responsibilities and assigned program areas may evolve over time based on departmental programmatic needs.
This role is critical to supporting the strategic expansion of non-malignant cellular therapy research while maintaining excellence in clinical care, regulatory compliance, and operational efficiency. The Nurse Manager will play a central role in scaling innovative therapies, leading teams, and ensuring successful study execution across a growing and complex portfolio.
Administrative Responsibilities:
- Supervises Clinical Research Coordinator positions and other CRNs to ensure protocol compliance, accurate data collection and sample acquisition.
- Develops educational programs for the Nursing Staff regarding specific protocols.
- Manage clinical trials portfolio and assure timely regulatory start-up of protocols.
- Monitor accruals and identify opportunities to grow research program.
- Liaison with industry sponsors and CROs.
- Liaison with CTO office (including pre-award and post award).
- Ability to motivate, develop and coach individuals.
- Manages human resources, inclusive of recruitment, hiring, evaluation, retention, progressive discipline and termination.
Responsibilities:
- Lead coordination and execution of non-malignant cellular therapy trials, including CAR-T and related therapies
- Provide direct nursing care as an integral member of the clinical research team to research study participants across multiple divisional teams.
- Implement the standards and training requirements for research protocols in compliance with regulatory, institutional and external agencies.
- Perform patient assessment, offer patient education and patient/family support.
- Participates in educating research subjects, families and healthcare team members on research study specifics and significant new information arising during conduct of trial including PEAK module development.
- Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment. Collaborates with Principal Investigator (PI) to determine patient eligibility for clinical trials, including documentation of criteria specified in the protocol.
- Participates in the planning of new protocol implementation on the patient care unit(s) and/or practice(s) including reviewing trials for feasibility and financial review, development and testing patient workflows and handoffs to ensure smooth subject participation, especially for studies involving multiple units.
- Serve as a liaison between research teams and key clinical stakeholders—including Bone Marrow Transplant (BMT) and Multiple Myeloma (MM) services, Apheresis, and the Cellular Therapy Laboratory—to ensure seamless communication, coordination, and alignment across studies. Develop and optimize cross-departmental work
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