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

Mount Sinai Health System•New York, NY

About The Position

The Clinical Program Manager provides clinical support and administrative direction for the Early Phase Clinical Trials Unit within the Tisch Cancer Center’s Clinical Trials Office and for the Department of Immunology and Immunotherapy. In collaboration with the Executive Director, clinical trials investigators, and the administrations of the TCI CCTO and DII, the role oversees implementation and conduct of clinical trials involving investigational anti-cancer agents and non-cancer interventions. The position requires expert knowledge of cancer, cancer treatment modalities, and clinical research. The manager follows a caseload of ambulatory patients and assists with administration and planning of the research program. Research responsibilities report to the CCTO Executive Director, while clinical responsibilities report to Ruttenberg Treatment Center Nursing Administration. The position supervises clinical research staff, manages the clinical trials portfolio and regulatory start-up, supports protocol compliance and data and sample collection, and coordinates study enrollment, treatment, follow-up, patient assessments, and documentation. It also collaborates with investigators and clinical staff to recruit eligible patients, provide patient care and education, and ensure that study procedures and investigational treatments follow protocol specifications. For clinical operations, the manager oversees compliance with mandated clinical interventions and core measures, working with Medical Center departments and clinical, nursing, medical, and quality leaders. The role supports compliance planning, education, program goals and procedures, daily program activities, and the collection and analysis of clinical program data.

Requirements

Baccalaureate degree in Nursing.
Five years of directly related experience.
New York State license and current registration as a registered professional nurse.
The posting states RN or NP is required in the title; the listed qualifications require a New York State registered professional nurse license and current registration.

Nice To Haves

Master’s degree in Nursing or a health-related field.
Some supervisory experience.
Certification in a specialty area, such as BCLS, ACLS, OCN, and/or AOCNP.

Responsibilities

Supervise Clinical Research Coordinator positions and other CRNs to support protocol compliance, accurate data collection, and sample acquisition.
Develop educational programs for nursing staff about specific protocols.
Manage the clinical trials portfolio and ensure timely regulatory start-up of protocols.
Monitor trial accruals and identify opportunities to grow the research program.
Liaise with industry sponsors, CROs, and the CCTO office, including pre-award, post-award, and QAP.
Coordinate study enrollment, establish patient databases, and coordinate protocol treatment and follow-up care for clinical trial participants.
Collaborate with primary nursing staff to provide nursing care to patients receiving clinical trial therapy.
Assist principal investigators in assuring adequate informed consent.
Ensure primary nursing staff understand how to administer investigational agents according to protocol specifications.
Ensure blood sampling and specimen preparation follow protocol specifications and monitor test results as appropriate.
Document clinical studies and therapy in patient charts and required databases.
Assess patients on study for therapy-related complications with nursing staff, and communicate findings to attending physicians and in medical records as required.
Ensure drug dosing and sample collection times are recorded on study worksheets.
Provide in-service training and serve as a resource to physicians, nurses, pharmacists, and other allied health professionals.
Communicate with referring and affiliated physicians to ensure clinical findings are documented throughout trials.
Collaborate with attending physicians to identify and recruit eligible patients for clinical trials.
Establish and maintain a CTMS database of prospective clinical trial patients.
Oversee scheduling of patient laboratory and radiologic assessments, admissions, and clinic visits.
Establish mechanisms for complete and accurate data collection and documentation.
Assure compliance with mandated clinical interventions and core measures within the department and Medical Center.
Coordinate core-measure and clinical-intervention compliance activities with Nursing, Medical, and Quality Leadership.
Assist in developing action plans and provide educational resources to departments and services on core-measure quality assessment and improvement processes.
Assist in establishing and implementing short- and long-term goals, objectives, policies, and operating procedures for core-measure programs.
Coordinate and lead day-to-day program activities as appropriate to program objectives and areas of expertise.
Oversee collection, compilation, and analysis of clinical program activity data.
Provide technical assistance, resource services, consultation, and education to clinical departments regarding core-measure activities.