Oncology Clinical Trials Program Manager

Mount Sinai; United States; On-site; USD 120,000 - 150,000; Full time

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. The Clinical Program Manager will report into the CCTO's Executive Director (for research responsibilities) and Ruttenberg Treatment Center's Nursing Administration (for clinical responsibilities).

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 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.

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 registere