Clinical Program Manager - Tisch Cancer Institute

The Clinical Program Manager provides clinical support and administrative direction for the Multiple Myeloma (MM) Program at Mount Sinai hospital.

In collaboration with the MM Medical Director, the Associate Director, and the clinical trials investigators; this candidate is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents at the Mount Sinai Hospital sites (The Mount Sinai Hospital (main site), The Blavatnik Family – Chelsea Medical Center at Mount Sinai and Mount Saini Brooklyn). 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 at our network sites and assist in the administration and plan of the research program.

The Clinical Program Manager will report into Associate Director.

Administrative Responsibilities: 

• Works with Clinical Research Coordinators and other clinical staff 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. 

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. 
• 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. 
• 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.  
• 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.
• Establishes mechanisms to ensure complete and accurate data collection and documentation.

Clinical Responsibilities: 

• The Network Clinical Program Manager is responsible for assuring compliance with mandated clinical interventions inclusive of core measures within the department and The Mount Sinai Health System. 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. 

Education:

• Bachelor’s Degree (BSN) (required) or Master’s Degree of Nursing (MSN) (preferred)with certification in Adult Primary Care, Adult Acute Care or Advanced Oncology Certified Nurse Practitioner (AOCNP).
• New York State License with current registration as a Registered Nurse and Nurse Practitioner with BCLS, ACLS certification. 
• Certification by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) desired. 

Experience:

• Five years of related clinical research experience; supervisory and oncology experience preferred.
• Thorough knowledge of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development proces