Job Description

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 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.

Clinical Responsibilities:

• 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.

Performs other job-related duties as required, which may include but not limited to:

• 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.
• Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers
• 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.

• Schedule may shift hours based on business needs with advance notice.

• 5 years’ experience in a hospital/medical environment and 1 year supervisory

Licensing and Certification Requirements

• Name: New York State Registered Nurse or Physician’s Associate
• Issuing Agency: Certified Physician Assistant by the National Commission on Certification of Physicians Assistant preferred, if applicable

Preferred:

• 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

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.