Mgr., Clinical Research Qual & Edu

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):

265 Crittenden Blvd, 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 114

Compensation Range:

$86,900.00 - $130,300.00

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 Manager leads and oversees the Regulatory and Compliance Team and oversees quality and education for the entire URCC NCORP Research Base, a $40M NIH-funded national clinical trial coordinating center overseeing a national network of 800+ community oncology practices. 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 8:00 am – 5:00 pm.

• Occasional work outside of standard business hours may be required. Some travel may be required periodically to conduct on-site monitoring visits throughout our national network.
• Reporting to the Asst. 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

The Manager is responsible for the ongoing quality control of research activities. The role provides ongoing quality assurance for research trials and supports activities to develop and manage education and training programs aligned with institutional standards for staff involved in conducting clinical research. The Manager provides support for all facets of clinical research, regulatory, compliance, auditing, and monitoring. The Manager oversees overall compliance of clinical research and protecting the rights and well-being of study participants related to research. The Manager oversees the Regulatory and Compliance Team and develops training for NCORP's 80+ staff members, investigators, and trainees, as well as for research staff across the NCORP network (1000s of personnel).

The Manager works closely with Research Base leadership, Study Chairs, cross-functional operational teams, and external collaborators to ensure regulatory compliance, quality, and education 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, as well as quality and education training for internal and external URCC NCORP RB stakeholders.

ESSENTIAL FUNCTIONS

Quality Assurance, Compliance, and Regulatory Training Oversight

• •Supervises and oversees staff across URCC, NCORP, and RB to develop training programs for high-quality research activities.
• •Develops and tracks quality metrics to identify areas needing procedural changes and/or supplemental education to ensure the Research Base maintains safe and compliant research.
• •Reviews and provides feedback on Corrective and Preventive Action Plans (CAPA) written in response to internal monitoring or external audit findings.
• •Acts as a resource to staff and investigators and NCORP Member sites in preparing for internal and external audits.
• •Develops the infrastructure necessary with the team to collect metrics required for NCI and CIRB reporting (e.g., accruals, publications, abstracts, awards, audits)
• •Oversees new processes for site and personnel rosters for national and local NCORP member sites
• •Develops new processes and procedures for workflows with other cross-functional Team Managers and trains investigators, Study Chairs, and staff across the NCORP network

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 Asst. Dir 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, Program Compliance Specialists, and Staff developing Training Programs
• •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 who report to them.
• •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