Clinical Program Manager, Early Phase Clinical Trials Unit (RN or NP Required) - Tisch Cancer Center

Mount Sinai; New York (NY); On-site; USD 115,000 - 192,000; Full time

Job summary

Mount Sinai Health System seeks a Clinical Program Manager to lead clinical trials within the Tisch Cancer Center and the Department of Immunology and Immunotherapy. You will supervise CRNs, develop training for nursing staff, manage trial portfolios, and coordinate regulatory startup activities in collaboration with executives and sponsors.

You will supervise patient enrollment, ensure informed consent, manage data in CTMS and clinical records, and lead core measures programs with nursing,

Qualifications

• Baccalaureate Degree in Nursing is required.
• Masters in Nursing or health related field is preferred.
• New York State License with current registration as a registered professional nurse.
• Certification in specialty area preferred (i.e. BCLS, ACLS, OCN and/or AOCNP).

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 CCTO office (including pre-award, post award and QAP).
• Coordinate study enrollment, establish a database of patients, protocol treatment and follow-up care.
• Collaborate with nursing staff to provide care for patients in clinical trials.
• Assist the PI in obtaining adequate informed consent.
• Ensure proper administration of investigational agents and sample collection per protocol.
• Document study data in patient charts and CTMS, monitor for protocol-related complications.
• Assess patients on study for therapy-related issues and report observations to physicians.
• Coordinate core measures and clinical intervention compliance activities with leadership.
• Provide training and resources to departments to support core measures quality improvement.

Education

Baccalaureate Degree in Nursing

Masters in Nursing or health related field

Job description

Description

Job Description. The Clinical Program Manager provides clinical support and administrative direction with both the Early Phase Clinical Trials Unit (EPTU) group within the Tisch Cancer Center's Clinical Trials Office (TCI CCTO) in addition to clinical support and administrative direction within the Department of Immunology and Immunotherapy (DII). In collaboration with the Executive Director, clinical trials investigators, and TCI CCTO and DII Administration; this candidate is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents in the Cancer Institute as well as on non-cancer interventions within DII. The Candidate must have expert knowledge of cancer as a disease process, cancer treatment modalities, and the process of conducting clinical research. The Candidate will follow a caseload of patients in the ambulatory setting and assist in the administration and plan of the research program.

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 CCTO office (including pre-award, post award and QAP).

Clinical Research Responsibilities

• Responsible for coordinating study enrollment, establishing a database of patients, protocol treatment and follow-up care for patients participating in clinical trials.
• Collaborates with primary nursing staff to provide nursing care to patients receiving therapy on a clinical research trial.
• Assists the principal investigator in the process of assuring adequate informed consent.
• Assures the primary nursing staff understands how to administer investigational agents per specifications of the protocol.
• Assures that blood sampling and specimen preparation is accomplished per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient’s chart and all other databases as required.
• In collaboration with the Nursing Staff, assesses patients on study for complications related to therapy.
• Communicates observations/findings to attending physicians and in medical records are required.
• Ensures that drug dosing and sample collections times are recorded on study worksheets.
• Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists, and other allied health care professionals.
• Communicates with referring and affiliated physicians to ensure documentation of clinical findings throughout the clinical trial.
• Collaborates with attending physicians to identify and recruit patients eligible for clinical trial.
• Establishes and maintains database of prospective patients for clinical trials within CTMS.
• Oversees scheduling of patient laboratory and radiologic assessments, admissions, and clinic visits.
• Establishes mechanisms to ensure complete and accurate data collection and documentation.

Clinical Responsibilities

• The Clinical Program Manager is responsible for assuring compliance with mandated clinical interventions inclusive of core measures within the department and the Medical Center. This individual interfaces directly with MSMC Departments, Administrators, Nursing, Medical and Quality Leadership, and Clinical Staff, overseeing administrative and daily operations of the core measures and clinical intervention compliance program.
• In conjunction with Nursing, Medical and Quality Leadership, coordinates core measures and clinical intervention compliance activities
• Assists in development and design of action plans to support compliance with measures indicators and provides support and educational resources to departments and services relative to core measures quality assessment and improvement processes.
• Assists in establishing and implementing short- and long-term goals, objectives, policies and operating procedures for core measures programs.
• Provides coordination and leadership in the execution of day-to-day program activities, as appropriate to program objectives and areas of expertise.
• Oversees the collection, compilation, and analysis of clinical program activity data.
• Provides technical assistance, resource services, consultation and education to clinical departments relative to core measures activities.

Qualifications

• Baccalaureate Degree in Nursing is required. Masters in Nursing or health related field is preferred
• 5 years directly related experience (some supervisory preferred)
• New York State License with current registration as a registered professional nurse
• Certification in specialty area preferred (i.e. BCLS, ACLS, OCN and/or AOCNP)

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 $115494 - $192328 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.