Clinical Trials Program Lead

Mount Sinai Health Systems; New York (NY); On-site; USD 115,000 - 192,000; Full time

Job summary

Mount Sinai Health System seeks a Clinical Program Manager to provide clinical support and administrative direction across the Early Phase Clinical Trials Unit and the Department of Immunology and Immunotherapy. The role oversees clinical trials with investigational cancer agents and coordinates study enrollment, data collection, and regulatory start-up.

Reporting to the Executive Director for research responsibilities and Nursing Administration for clinical responsibilities, the incumbent will

Qualifications

• Baccalaureate Degree in Nursing is required. Masters in Nursing or health related field preferred.
• 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 (i.e. BCLS, ACLS, OCN and/or AOCNP)

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).
• Coordinate study enrollment, establish a database of patients, protocol treatment and follow-up care for patients in clinical trials.
• Collaborates with primary nursing staff to provide nursing care to patients receiving therapy on a clinical research trial.
• Assist PI in ensuring informed consent.
• Ensure proper administration of investigational agents per protocol.
• Document study and therapy in patient charts and CTMS databases.
• Collaborates with attending physicians to recruit patients eligible for trials.
• Oversee scheduling of lab and radiologic assessments and clinic visits.

Skills

Clinical program management

Supervisory experience

Regulatory knowledge

Education

Bachelor of Science in Nursing

Job description

Mount Sinai Health System seeks a Clinical Program Manager to provide clinical support and administrative direction across the Early Phase Clinical Trials Unit and the Department of Immunology and Immunotherapy. The role oversees clinical trials with investigational cancer agents and coordinates study enrollment, data collection, and regulatory start-up.

Reporting to the Executive Director for research responsibilities and Nursing Administration for clinical responsibilities, the incumbent will