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

Clinical Research Nurse Manager – Cellular Therapy

The Clinical Trials Office is seeking a highly skilled Clinical Research Nurse Manager to support and lead a growing portfolio of cellular therapy clinical research. The primary focus will be on non-malignant CAR-T and cellular therapy studies, with transitional support for malignant Bone Marrow Transplant (BMT)/Cellular Therapy programs.

This role initially allocates effort evenly between non-malignant (50%) and malignant (50%) programs, with the non-malignant portfolio expected to expand over time. The position ensures participant safety, protocol adherence, and regulatory compliance while collaborating with investigators and multidisciplinary teams to support successful study execution and data integrity.

This is a dual-reporting role (Tisch Cancer Institute and departmental clinical research teams) requiring strong communication, adaptability, and the ability to function effectively in a matrixed environment. Responsibilities may evolve based on programmatic needs.

Key Responsibilities

Leadership & Administration:

• Supervise Clinical Research Coordinators and Clinical Research Nurses to ensure protocol compliance and data integrity
• Manage clinical trial portfolio, including regulatory start-up and accrual tracking
• Partner with sponsors, CROs, and the Clinical Trials Office
• Lead staff development, hiring, coaching, and performance management
• Develop and deliver protocol-specific education for nursing staff

Clinical Research Operations:

• Lead coordination and execution of non-malignant cellular therapy trials (including CAR-T)
• Provide direct patient care, assessments, and education
• Collaborate with PIs to determine eligibility and ensure protocol adherence
• Oversee informed consent processes in compliance with FDA, GCP, and IRB requirements
• Support feasibility assessments, workflow development, and study implementation

Cross-Functional Coordination:

• Serve as liaison across BMT, Multiple Myeloma, Apheresis, Cellular Therapy Lab, and research teams
• Optimize workflows for study activation, scheduling, and sample handling

Regulatory & Compliance:

• Ensure compliance with IRB, FDA, sponsor, and institutional requirements
• Report adverse events and support audits and monitoring visits
• Maintain accurate regulatory documentation

Clinical & Program Oversight:

• Support clinical quality initiatives and compliance with care standards
• Provide education and operational guidance to clinical teams
• Lead day-to-day program operations and continuous improvement efforts

Additional Responsibilities

• Support protocol planning, study initiation, and monitoring visits
• Train staff on clinical skills and research procedures
• Participate in investigator meetings and institutional training
• Foster a collaborative, high-performing team environment

Qualifications

Education Requirements

• Bachelor’s degree in Nursing or Certified Physician Associate

Experience Requirements

• 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

Employer Description

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.

Compensation

The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $95450 - $ Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.