Mgr., Clinical Research Qual & Edu

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• 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.

• 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

• 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

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

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