Job Description

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

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 regulatory guidance throughout the clinical trial lifecycle, including study development, activation, conduct, reporting, and closeout.

Team Leadership and Staff Management

• Directly supervises Regulatory Specialists, Quality Assurance Specialists, and Program Compliance Specialists.
• Establishes team priorities, workload distribution, performance expectations, and resource allocation to support Research Base objectives.
• Provides onboarding, training, mentoring, coaching, and professional development opportunities for staff.
• Conducts performance evaluations and manages employee relations activities, including corrective action, promotions, retention, and recruitment efforts.
• Ensures effective cross-training, communication, and operational continuity through appropriate staffing and coverage plans.
• Promotes a culture of compliance, accountability, continuous improvement, and customer service.

Regulatory Operation and Clinical Trial Compliance

• Oversees regulatory compliance activities for all Research Base studies and participating network sites.
• Directs the collection, review, maintenance, and archival of essential regulatory documents, including FDA Forms 1572, IRB approvals, investigator credentials, delegation logs, and other study-related regulatory records.
• Ensures compliance with NIH/NCI funding requirements, CIRB and local IRB regulations, credentialing requirements, reporting obligations, and research dissemination requirements.
• Provides regulatory review and oversight of study protocols, informed consent documents, investigator training materials, and study implementation plans.
• Supports investigators in regulatory submissions and reporting activities, including IND-related requirements when applicable.
• Monitors regulatory developments and communicates changes in applicable regulations, guidance, and best practices to internal and external stakeholders.

Auditing, Monitoring, and Quality Assurance

• Leads the Research Base audit and monitoring program to ensure compliance with protocol requirements, GCP standards, CTMB Guidelines, and federal regulations.
• Oversees planning, execution, and follow-up of site monitoring visits and audits conducted throughout the national clinical trials network.
• Reviews and approves audit and monitoring reports, corrective and preventive action plans (CAPAs), and site remediation activities.
• Serves as the primary contact for auditing and monitoring interactions with investigators, site personnel, CTMB representatives, IRBs, and institutional review committees.
• Evaluates compliance trends, identifies areas of risk, and implements quality improvement initiatives to strengthen regulatory performance across the Research Base.
• Maintains and updates Research Base auditing and monitoring procedures to align with evolving regulatory requirements and industry best practices.

Data Safety Coordinator

• Serves as the NCORP Research Base Data Safety Monitor, collaborating with project and data management teams to prepare detailed reports for the WCI DSMC, and attending their monthly meetings as a non-voting member of the committee.

Other duties as required

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years research regulatory related experience required
• Master's degree preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to act with minimal direction and considerable latitude for independent judgment required
• Extensive working knowledge of Good Clinical Practice guidelines applicable to study implementation, including development and interpretation of protocol as it relates to the required regulatory documents, required
• Ability to keep current with industry standards and federal regulations relevant to sponsored studies required
• Excellent verbal and writing skills required
• Strong interpersonal, analytical, spreadsheet development and analysis, and technical skills preferred
• Strong problem-solving ability, and ability to work both independently and collaboratively within a team preferred
• Strong organizational skills, attention to detail, and ability to manage multiple projects and priorities preferred
• Fully adheres to applicable safety and/or infection control standards preferred.
• Ability to mentor and provide training to junior members of the team preferred.
• Ability to effectively manage moderately complex research protocols/procedures preferred.
• Possesses a high degree of self-motivation preferred.
• Recognized ability to function independently preferred.
• Proficient in managing multiple and competing priorities/demands preferred.
• Detail-oriented in record keeping and research documentation preferred.
• Understands and follows data integrity standards and processes preferred.
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation preferred.
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred.
• Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet preferred.

LICENSES AND CERTIFICATIONS

• CLASP certification required

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.