Sr. Reg Affairs & Compl Spec

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. **Job Location (Full Address):** 601 Elmwood Ave, Rochester, New York, United States of America, 14642 **Opening:** Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400119 Surgery-Cancer Control Work Shift: UR - Day (United States of America) Range: UR URG 112 Compensation Range: $70,600.00 - $105,800.00 *The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.* **Responsibilities:** The Sr. Regulatory Affairs and Compliance Specialist leads and oversees the Regulatory and Compliance Team for the URCC NCORP Research Base, a $40M NIH-funded national clinical trial coordinating center overseeing a national network of 800+ community oncology practices. Reporting to the Executive Director of Research Operations, this role oversees all regulatory, auditing, and NCORP program compliance across the Research Base clinical trial portfolio, which includes multisite Phase II and III cancer control and cancer care delivery clinical trials. This role oversees regulatory compliance across the NCORP network of clinical sites, and ensures adherence to federal regulations, program guidelines, and institutional policies. The Sr. Specialist works closely with Research Base leadership, Study Chairs, cross-functional operational teams, and external collaborators to ensure regulatory and compliance activities are efficient, effective, and aligned with Research Base priorities. This position is responsible for creating and maintaining SOPs and is the most senior liaison for regulatory and compliance matters for internal and external URCC NCORP RB stakeholders. The Research Base is part of the Department of Surgery, Division of Supportive Care in Cancer, with our offices located in the Saunders Research building. This role is required to be in-office, with work hours/availability during standard business hours, within approximately 8:00am – 5:00pm. Occasional work outside of standard business hours may be required. Some travel may periodically be required to perform on-site monitoring visits throughout our national network. **ESSENTIAL FUNCTIONS** **Regulatory Affairs and Program Compliance Leadership** - Serves as the senior regulatory and compliance leader for the URCC NCORP Research Base, providing strategic oversight of regulatory affairs, quality assurance, auditing, and program compliance activities across a national network of clinical research sites. - Reports directly to the Executive Director of Research Operations and provides regular updates to Research Base leadership regarding regulatory initiatives, compliance metrics, risks, audit outcomes, and program requirements. - Ensures organizational compliance with NIH, NCI, FDA, OHRP, CTMB, ClinicalTrials.gov, Good Clinical Practice (GCP), and other applicable federal regulations, program guidelines, and institutional policies. - Develops, implements, and maintains policies, procedures, and standard operating procedures (SOPs) governing regulatory compliance, monitoring, auditing, and quality management activities. - Serves as the primary regulatory and compliance liaison for internal and external stakeholders, including investigators, Study Chairs, Research Base leadership, NCI program officials, CIRB representatives, DSMC members, and collaborating institutions. - Provides expert re…