Montefiore Medical Center
Location
Bronx, NY | United States
Job description
The MECCC Protocol Review and Monitoring System is an NCI required committee charged with assessing the scientific merit, progress and continued relevance of all cancer related clinical studies conducted at the institution. The Clinical Research Program Manager- Protocol Review and Monitoring System (PRMS), under the supervision of the Assistant Director Regulatory Compliance within the Cancer Clinical Trials Office Business Unit, is responsible for supporting the development, review and approval process for all oncology-related clinical studies at the Montefiore Einstein Comprehensive Cancer Center. The PRMS Program Manager will staff the PRMS, support the Chair(s) in all PRMS activities, and coordinate and manage the process and flow of protocols from Disease and Modality Team (DMT) review through PRMS approval. This includes new protocols and as well amendments.
In addition, the Program Manager will serve as the Administrator for the individual Disease and Modality Teams (DMTs) and for the Investigator Initiated Support Service, shepherding protocols through the review and approval process from concept to award. This includes staffing and supporting the multiple committee reviews and supporting the faculty leadership.
Requirements
Bachelor’s Degree Required
Master’s Degree Preferred
Minimum 2 years of experience working in an Institutional Review Board Office or Clinical Trials Office focused on regulatory compliance.
Demonstrated knowledge proficiency of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research
Strong working knowledge of NCI regulations and requirements.
Analytical and critical thinking skills to recognize trends
Demonstrated ability to manage projects: ability to prioritize, identify barriers and meet deadlines
Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously
Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others
Demonstrated skill in working with minimal supervision
Effective written and verbal communication
Department: CANCER CLINICAL TRIALS OFFICE Bargaining Unit: Non Union Campus: MOSES Employment Status: Regular Full-Time Address: 1695 Eastchester Road, Bronx
Shift: Day Scheduled Hours: 9 AM-5:30 PM Req ID: 218585 Salary Range/Pay Rate: $67,500.00- $90,000.00
For positions that have only a rate listed, the displayed rate is the hiring rate but could be subject to change based on shift differential, experience, education or other relevant factors.
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Diversity, equity and inclusion are core values of Montefiore. We are committed to recruiting and creating an environment in which associates feel empowered to thrive and be their authentic selves through our inclusive culture. We welcome your interest and invite you to join us.
Montefiore is an equal employment opportunity employer. Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.
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