Clinical Research Manager Licensed (RN) - Medicine Clinical Trials Office

Mount Sinai Health System•New York, NY

About The Position

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.

Requirements

Bachelor’s degree in Nursing or Certified Physician Associate
5 years’ experience in a hospital/medical environment
1 year supervisory experience
New York State Registered Nurse or Physician’s Associate
Certified Physician Assistant by the National Commission on Certification of Physicians Assistant preferred, if applicable
New York State RN license
Bachelor of Science degree in Nursing, BCLS and ACLS Required.
A minimum of 2-5 years of nursing experience required.
Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, infusions, etc.) at time of hire.
Clinical research nursing experience highly preferred.
Cellular Therapy coordination or administration experience recommended
Good Clinical Practice training required.
Proven organizational skills including attention to detail and multi-tasking skills.
Progressive managerial and clinical job related experience specific to area of responsibility.
5 years directly related experience hospital/medical environment
Experience in a supervisory capacity preferred.
Demonstrates the ability to quickly learn and navigate multiple internal and external electronic systems with accuracy and efficiency.
Proficient in Microsoft Office 365 (Excel, Word, Outlook, Teams, SharePoint) and comfortable troubleshooting basic technical issues.
Experience with electronic health systems or research databases is preferred, or a strong willingness to learn

Nice To Haves

Certified Physician Assistant by the National Commission on Certification of Physicians Assistant preferred, if applicable
Clinical research nursing experience highly preferred.
Cellular Therapy coordination or administration experience recommended
Experience with electronic health systems or research databases is preferred, or a strong willingness to learn

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.
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 workflows to support efficient study activation, participant scheduling, sample handling, and protocol-driven operational processes.
Obtain informed consent after delegation by the study investigator(s).
Ensures initial/ongoing consent process is performed and documented in compliance with the US Food and Drug Administration (FDA), Good Clinical Practice, institutional policies, SOPs (Standard Operating Procedures), sponsor requirements, Institutional Review Board (IRB) and related applicable regulations, guidelines and policies.
Perform research related activities for clinical research studies including but not limited to: answering phone calls/emails, screening participants for eligibility, ordering research protocol related tests, data entry, query resolution, regulatory documentation, and administering lifestyle questionnaires.
Performs clinical procedures including, but not limited to, vital signs, phlebotomy, specimen collection, electrocardiograms, administration of investigational agent (under PI supervision), IV placement, catheters and patient assessment/questionnaire completion.
Administers investigational medications and performs patient assessments during clinic visit to determine presence of side effects & notifies Principal Investigator of findings/issues.
May need to secure, deliver, and ship laboratory samples, radiographs, and other clinical specimens as required by protocol.
Perform clinical/division specific procedures after any necessary trainings and assessments (i.e. Fibroscan, sputum induction or clinical testing) as specified per study protocol.
Evaluates disease response results and physical assessment data in Source and EMR, in conjunction with PI, to determine response per protocol.
Reports deviations and variances to the research team
Initiates service recovery for research patients and family members who have concerns and escalates to Principal Investigator/Sub-Investigator, Clinical Nurse Manager/Assistant Nurse Manager/Nursing Shift Manager, Investigational Review Board or Patient Relations as needed.
Ability to work independently and collaboratively in a matrixed environment.
Ensure proper compliance with institutional and regulatory requirements : Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) or IRB of Record, SOPs, sponsor guidelines, and federal regulations.
Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
Participates in related audit preparation and facilitation, including FDA, IRB and related internal and external monitors and auditors.
Ensures compliance with core clinical measures and mandated interventions, coordinating with leadership and clinical departments across the Medical Center
Supports development and implementation of action plans, policies, and performance goals to drive quality improvement
Leads day-to-day program operations while providing guidance, education, and technical support to clinical teams on compliance initiatives.
Participates in research project planning to determine feasibility of protocol implementation based on knowledge of institutional capabilities/limitations, therapy, and/or population of interest.
Participate in Investigators’ Meeting and assist with coordinating Study Initiation Visits.
Attend divisional/departmental/institutional educational and training seminars.
Facilitate sponsor driven monitoring visits.
Train new staff for competency on common clinical skills.
Committed and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and passion.
A good decision-maker, with proven success at making timely decisions that maintain high standards of nursing care within the organization.
An effective communicator, capable of determining how best to reach different audiences and driving communications based on that understanding.
Capable of building strong customer relationships and delivering customer-centric solutions.