DescriptionThe Clinical Program Manager is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents in the Cancer Institute. The Candidate must have expert knowledge of cancer as a disease process cancer treatment modalities and the process of conducting clinical research. The CPM will follow a caseload of patients in the ambulatory setting and assist in the administration and plan of the research program. This position will be primarily assigned to our Downtown Clinical Research Programs which operate at Mount Sinai West and Mount Sinai Chelsea but is expected to move throughout the health care system based on patient needs.
ResponsibilitiesClinical Responsibilities:
- Provides exemplary patient care while ensuring the protocol is conducted in a high-quality manner and clinical research documentation is inspection ready.
- Responsible for coordinating study enrollment establishing a database/case load of patients protocol treatment and follow-up care for patients participating in clinical trials.
- Responsible for ensuring protocol adherence and accurate source data. Implement the standards for research protocols in compliance with regulatory institutional and external agencies
- Collaborates with attending physicians to identify and recruit patients eligible for clinical trial. Oversees scheduling of patient laboratory and radiologic assessments admissions and clinic visits and supports investigators with the informed consent process and documentation.
- Evaluate treat and/or triage untoward reactions according to the standard of care and protocol guidelines prescribe and manage supportive care medications.
- Assures the primary nursing staff understands how to administer investigational agents per specifications of the protocol.
- Ensures accurate and timely research documentation and works with ancillary departments (i.e. infusion radiology etc.) to ensure research is integrated into standard clinical operations.
Education Responsibilities:
- Develops educational content and delivers nurse-to-nurse education specifically the education of Nursing Staff regarding specific protocol requirements treatment administration of investigational agents coordination of timed or sequenced events (i.e. serial vitals) and the accurate capture of clinical data for the purposes of the study and patient monitoring.
- Teach coach and mentor junior staff; serves as preceptor
- Provides routine and ongoing education to patients and families; serves as patient advocate
Quality:
- Reports unexpected and unanticipated events to institutional offices and committees (i.e. Data safety monitoring institutional review board etc.)
- Facilitates in/external monitoring and auditing; leads quality improvement and process improvement projects
- Responsible for ensuring compliance with core measures and national standards are continuously met and collaborates with key departments Administrators Nursing Medical and Quality Leadership and Clinical Staff to coordinate such activities.
- Assists in development and execution 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.
Administrative Responsibilities:
- Establish and implement effective recruitment and outreach strategies to promote access inclusion and participation in clinical trials.
- Participates in the collection compilation and analysis of clinical program activity data and reports on unit productivity.
- 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.
- Monitor clinical trial portfolio and enrollments to identify opportunities to grow research program.
- May supervise licensed or unlicensed staff to ensure protocol compliance accurate data collection and sample acquisition.
Qualifications- Baccalaureate Degree in Nursing is required. Masters Degree preferred; or Advanced Oncology Certified Nurse Practitioner (AOCNP).
- 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.
- Progressive managerial and clinical job related experience specific to area of responsibilities.
- Certification in specialty area preferred.
Required Experience:
Manager
DescriptionThe Clinical Program Manager is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents in the Cancer Institute. The Candidate must have expert knowledge of cancer as a disease process cancer treatment modalities and the process of conduct...
DescriptionThe Clinical Program Manager is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents in the Cancer Institute. The Candidate must have expert knowledge of cancer as a disease process cancer treatment modalities and the process of conducting clinical research. The CPM will follow a caseload of patients in the ambulatory setting and assist in the administration and plan of the research program. This position will be primarily assigned to our Downtown Clinical Research Programs which operate at Mount Sinai West and Mount Sinai Chelsea but is expected to move throughout the health care system based on patient needs.
ResponsibilitiesClinical Responsibilities:
- Provides exemplary patient care while ensuring the protocol is conducted in a high-quality manner and clinical research documentation is inspection ready.
- Responsible for coordinating study enrollment establishing a database/case load of patients protocol treatment and follow-up care for patients participating in clinical trials.
- Responsible for ensuring protocol adherence and accurate source data. Implement the standards for research protocols in compliance with regulatory institutional and external agencies
- Collaborates with attending physicians to identify and recruit patients eligible for clinical trial. Oversees scheduling of patient laboratory and radiologic assessments admissions and clinic visits and supports investigators with the informed consent process and documentation.
- Evaluate treat and/or triage untoward reactions according to the standard of care and protocol guidelines prescribe and manage supportive care medications.
- Assures the primary nursing staff understands how to administer investigational agents per specifications of the protocol.
- Ensures accurate and timely research documentation and works with ancillary departments (i.e. infusion radiology etc.) to ensure research is integrated into standard clinical operations.
Education Responsibilities:
- Develops educational content and delivers nurse-to-nurse education specifically the education of Nursing Staff regarding specific protocol requirements treatment administration of investigational agents coordination of timed or sequenced events (i.e. serial vitals) and the accurate capture of clinical data for the purposes of the study and patient monitoring.
- Teach coach and mentor junior staff; serves as preceptor
- Provides routine and ongoing education to patients and families; serves as patient advocate
Quality:
- Reports unexpected and unanticipated events to institutional offices and committees (i.e. Data safety monitoring institutional review board etc.)
- Facilitates in/external monitoring and auditing; leads quality improvement and process improvement projects
- Responsible for ensuring compliance with core measures and national standards are continuously met and collaborates with key departments Administrators Nursing Medical and Quality Leadership and Clinical Staff to coordinate such activities.
- Assists in development and execution 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.
Administrative Responsibilities:
- Establish and implement effective recruitment and outreach strategies to promote access inclusion and participation in clinical trials.
- Participates in the collection compilation and analysis of clinical program activity data and reports on unit productivity.
- 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.
- Monitor clinical trial portfolio and enrollments to identify opportunities to grow research program.
- May supervise licensed or unlicensed staff to ensure protocol compliance accurate data collection and sample acquisition.
Qualifications- Baccalaureate Degree in Nursing is required. Masters Degree preferred; or Advanced Oncology Certified Nurse Practitioner (AOCNP).
- 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.
- Progressive managerial and clinical job related experience specific to area of responsibilities.
- Certification in specialty area preferred.
Required Experience:
Manager
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