Mgr., Clinical Research Qual & Edu

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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:

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 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 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

KNOWLEDGE, SKILLS AND ABILITIES

• 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

LICENSES AND CERTIFICATIONS

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

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