Clinical Program Manager, Early Phase Clinical Trials Unit (RN or NP Required) - Tisch Cancer Center
About The Position
The Clinical Program Manager provides clinical support and administrative direction to the Early Phase Clinical Trials Unit (EPTU) within the Tisch Cancer Center’s Clinical Trials Office (TCI CCTO), as well as to the Department of Immunology and Immunotherapy (DII). In collaboration with the Executive Director, clinical trials investigators, and TCI CCTO and DII Administration, the role supports implementation and conduct of clinical trials involving investigational anti-cancer agents and non-cancer interventions within DII. 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. The role reports to the CCTO Executive Director for research responsibilities and Ruttenberg Treatment Center Nursing Administration for clinical responsibilities. It combines administrative oversight, clinical research coordination, patient care collaboration, and leadership of clinical intervention and core-measures compliance activities.
Requirements
- Bachelor’s degree in Nursing.
- Five years of directly related experience.
- New York State license and current registration as a registered professional nurse.
- Expert knowledge of cancer as a disease process, cancer treatment modalities, and the process of conducting clinical research.
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 ensure protocol compliance, accurate data collection, and sample acquisition.
- Develop educational programs for nursing staff regarding specific protocols.
- Manage the clinical trials portfolio and ensure timely regulatory start-up of protocols.
- Monitor 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 oversee protocol treatment and follow-up care for clinical-trial participants.
- Collaborate with primary nursing staff to provide nursing care to patients receiving therapy on clinical research trials.
- Assist principal investigators in ensuring 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 in collaboration with nursing staff.
- Communicate observations and findings to attending physicians and document them 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 documentation of clinical findings throughout trials.
- Collaborate with attending physicians to identify and recruit eligible clinical-trial patients.
- Establish and maintain a CTMS database of prospective clinical-trial patients.
- Oversee scheduling of laboratory and radiologic assessments, admissions, and clinic visits.
- Establish mechanisms for complete and accurate data collection and documentation.
- Oversee administrative and daily operations of core-measures and clinical-intervention compliance programs, interfacing with departments, administrators, nursing, medical and quality leadership, and clinical staff.
- Coordinate core-measures and clinical-intervention compliance activities with nursing, medical, and quality leadership.
- Help develop action plans and provide educational resources to support measure compliance and quality assessment and improvement.
- Help establish and implement short- and long-term goals, objectives, policies, and operating procedures for core-measures programs.
- Coordinate and lead day-to-day program activities in support of program objectives and areas of expertise.
- Oversee collection, compilation, and analysis of clinical program activity data.
- Provide technical assistance, consultation, resource services, and education to clinical departments on core-measures activities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
