SENIOR REGULATORY CONSULTANT

Job Details City/State: Bronx, New York Grant Funded: Yes Department: Cancer Clinical Trials Office Work Shift: Day Work Days: MON-FRI Scheduled Hours: 9 AM-5:30 PM Scheduled Daily Hours: 7.5 HOURS Pay Range: $72,000.00-$90,000.00 Overview A Senior Regulatory Compliance Coordinator works under the direction of the Director of Regulatory Affairs and Compliance in the Cancer Clinical Trials Office at the Montefiore Einstein Comprehensive Cancer Center. The incumbent will work with investigators and the CCTO infrastructure to manage cancer clinical trials for the division. Responsibilities Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, developing new clinical trials and acting as the main contact during the protocol development phase, corresponding with the reviewing committees and personnel, assisting in budget development by identifying research non-billables, and coordinating start‑up meetings for new protocols. The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff—providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams. Qualifications Education Requirements: Bachelor’s Degree Required (preferred Life Science or Health Policy); preferred Master’s Degree (preferred Life Science or Health Policy). Certifications: SOCRA or ACRP certification preferred. Prior Experience: Minimum 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance. Equal Opportunity Statement Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center 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. #J-18808-Ljbffr