Mgr., Clinical Research Qual & Edu

About the role

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.

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
• Performs other duties as required

Qualifications

• Bachelor's degree and 7 years of relevant experience required
• 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

Skills

• 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

Certifications

• CCRP - Certified Clinical Research Professional within 1 year required
• SOCRA - Certification In Clinical Research within 1 year required

Schedule

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.

Pay

$86,900.00 - $130,300.00