Regulatory & Quality Manager, Clinical Research

Grade 105

• Job Type: Officer of Administration
• Regular/Temporary:
  Regular
• Hours Per Week: 35
• Salary Range: $71,400 to $73,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Regulatory Manager provides operational and strategic oversight of regulatory compliance and quality assurance activities across assigned clinical research portfolios.

This role supervises regulatory staff, ensures audit readiness, mitigates compliance risk, and implements standardized documentation and monitoring processes aligned with institutional, sponsor, and federal requirements.

The Regulatory Manager holds accountability for regulatory infrastructure, documentation standards, audit outcomes, and staff performance within the assigned research environment and serves as the primary escalation point for regulatory and quality concerns.

Responsibilities

• Oversees regulatory lifecycle management across assigned protocols, including start-up, maintenance, and closure activities.
• Prepares consent forms, monitor date of approvals and communicate to research coordinators at the time IRB approves and stamps new consents.
• Prepares submissions for the Joint Radiation Safety Committee and oversees submission of JRSC annual submission (being incorporated into RASCAL).
• Prepares Cost Estimates for research pharmacy, radiation and anesthesiology in collaboration with finance manager.
• Provides final review and approval of complex submissions and compliance documentation as required.
• Participates in investigator meetings, site initiation visits and monitoring visits, if needed.
• Implements and monitors quality control mechanisms to ensure consistency, accuracy, and audit readiness of regulatory documentation.
• Serves as escalation authority for high-risk regulatory issues and quality concerns.
• Ensures adherence to institutional policies, HIPAA, ICH-GCP, FDA regulations (21 CFR), OHRP guidance, sponsor requirements, and local/state compliance frameworks.

Quality and Monitoring Support

• Oversees preparation and execution of sponsor monitoring visits, internal audits, federal inspections, and accreditation reviews.
• Reviews audit findings and approves corrective and preventive action (CAPA) plans.
• Monitors resolution of compliance findings and ensures systemic process improvement.
• Analyzes audit trends and compliance metrics to identify recurring risks and operational vulnerabilities.
• Provides periodic compliance and quality reports to leadership.

Process Improvement

• Develops, implements, and revises regulatory and quality workflows, SOPs, templates, and documentation standards.
• Identifies inefficiencies, documentation gaps, and compliance vulnerabilities and implements corrective process enhancements.
• Leads initiatives to standardize regulatory documentation and monitoring frameworks across research teams.
• Collaborates with research leadership to improve operational consistency, reduce audit risk, and enhance regulatory infrastructure.
• Supports development of tracking tools and dashboards to monitor regulatory performance indicators and quality metrics.
• Participates in institutional committees related to research compliance, governance, and quality initiatives.

Compliance and Documentation

• Ensures assigned research portfolio maintains complete, accurate, and audit-ready regulatory documentation at all times.
• Oversees documentation standards across regulatory systems and shared repositories.
• Monitors adherence to federal, state,…