The Clinical Program Manager provides clinical support and administrative direction for the Novel Therapeutics Program (NTP: Phase I – First in Human Research Program) within the Tisch Cancer Institute’s Clinical Trials Office (TCI CCTO).
In collaboration with the NTP Medical Director, clinical trials investigators, and TCI CCTO Administration; this candidate 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 Candidate will follow a caseload of patients in the ambulatory setting and assist in the administration and plan of the research program.
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.
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.
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.
NYS RN with BCLS, ACLS, DEA, OCN RN or Master's Degree.
Oncology experience preferred.
Clinical Trials experience preferred.
Who We Are:
Over 35,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is committed to the tenets of diversity and workforce that are strengthened by the inclusion of and respect for our differences. We offer our employees a highly competitive compensation and benefits package, a 403(b) retirement plan, and much more.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.
Internal Number: # 2686344
About Icahn School of Medicine
The Icahn School of Medicine at Mount Sinai is an international leader in medical and scientific training, biomedical research, and patient care. It is the medical school for the Mount Sinai Health System, which includes eight hospital campuses, and has more than 5,000 faculty and nearly 2,000 students, residents and fellows. Our unwavering pursuit of intellectual exchange, breakthrough research, and multidisciplinary teamwork propels us ever forward in biomedical discoveries and advances. We pursue ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients. We make big, bold bets by investing in radical free thinkers and technology at the cutting edge.