Mgr., Clinical Research Qual & Edu

University of Rochester•City of Rochester, NY

78d•$86,900 - $130,300•Onsite

About The Position

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.

Requirements

Bachelor's degree and 7 years of relevant experience required
CCRP - Certified Clinical Research Professional within 1 year required
SOCRA - Certification In Clinical Research within 1 year required

Nice To Haves

Master's degree preferred
Or equivalent combination of education and experience
5 years of progressively responsible work experience in the administrative management of clinical research staff preferred
Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards preferred
Proficiency in managing multiple and competing priorities/demands preferred
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
Fully adheres to applicable safety and/or infection control standards preferred
Exceptional interpersonal, organizational, and time management skills 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, internet preferred
Possesses a high degree of self-motivation preferred
Recognized ability to function independently preferred

Responsibilities

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
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.
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.
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.
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.
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