About The Position

The Clinical Program Manager provides clinical support and administrative direction to the Early Phase Clinical Trials Unit within the Tisch Cancer Center’s Clinical Trials Office and to the Department of Immunology and Immunotherapy. In collaboration with the Executive Director, clinical trial investigators, and administrative teams, the role supports implementation and conduct of clinical trials involving investigational anti-cancer agents and non-cancer interventions. The position requires expert knowledge of cancer, cancer treatments, and clinical research. The manager follows patients in the ambulatory setting and helps administer and plan the research program. The role reports to the CCTO Executive Director for research responsibilities and to Ruttenberg Treatment Center Nursing Administration for clinical responsibilities. It combines supervision and research-program administration with coordination of clinical trial activities and patient care, as well as oversight of clinical intervention and core-measure compliance programs.

Requirements

  • Baccalaureate degree in Nursing.
  • At least 5 years of directly related experience.
  • Current New York State license and registration as a registered professional nurse.
  • Expert knowledge of cancer as a disease process, cancer treatment modalities, and clinical research processes.

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 CCTO offices, including pre-award, post-award, and QAP.
  • Coordinate study enrollment, maintain patient databases, and arrange protocol treatment and follow-up care for clinical trial participants.
  • Collaborate with primary nursing staff to provide care to patients receiving clinical-trial therapy.
  • Assist principal investigators with obtaining 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; 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, 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 clinical trials.
  • Collaborate with attending physicians to identify and recruit eligible 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.
  • Assure compliance with mandated clinical interventions and core measures within the department and Medical Center.
  • Interface with departments, administrators, nursing, medical and quality leadership, and clinical staff to oversee daily operations of core-measure and clinical-intervention compliance programs.
  • Coordinate core-measure and clinical-intervention compliance activities with Nursing, Medical, and Quality Leadership.
  • Help develop action plans and provide educational resources to support compliance with measure indicators and quality assessment and improvement processes.
  • Help establish and implement short- and long-term goals, objectives, policies, and operating procedures for core-measure 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 regarding core-measure activities.
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