Regulatory Services Manager – National Center for Clinical Trials

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provides comprehensive administrative leadership and coordination of Regulatory Services for NCCT clinical research.

• Ensures adherence to institutional, IRB, federal, and other relevant regulatory standards throughout clinical trials.

• Supervises and advises staff on IRB submissions, HIPAA compliance, and regulatory communications.

• Develops, implements, and enforces policies, procedures, and tools that support compliant and efficient research operations.

• Leads the hiring, training, performance management, coaching, and professional development of regulatory staff.

• Oversees initial and ongoing IRB reviews, amendments, reportable events, and study closures.

• Monitors regulatory documents and ensures the timely completion of submissions and approvals.

• Maintains compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and departmental SOPs.

• Prepares for, manages, and responds to audits and inspections.

• Directs responses to audit findings and coordinates CAPA plans.

• Manages regulatory projects and workflows, overseeing timelines, deliverables, risks, and barriers.

• Allocates regulatory staff resources across study portfolios and departmental priorities.

• Communicates regulatory status, risks, and compliance issues to investigators, study teams, and leadership.

• Monitors regulatory changes and leads necessary process or policy updates.

• Supports protocol development, study initiation, and close-out activities.

• Maintains relationships with stakeholders, sponsors, IRB, and regulatory agencies.

• Coordinates regulatory metrics, reports, and compliance analyses.

• Participates in research compliance and regulatory affairs meetings and committees.

• Assists leadership with regulatory policies and quality initiatives.

• Manages special regulatory projects and performs related duties.

⛳️ Requirements

• Master's degree in a relevant field such as Health Administration, Nursing, Business, or Basic Science with three years of pertinent management experience; or an equivalent combination of education and experience.

• Experience in a medical/research setting is preferred.

• Excellent verbal and written communication abilities.

• Understanding of scientific and statistical concepts.

• Willingness to travel to affiliate sites, clinical sites, and national meetings.

• Familiarity with institutional and governmental regulations and guidelines pertaining to clinical research.

• Knowledge of Good Clinical Practices elements.

• Availability to work Monday through Friday, from 8 AM to 4:30 PM.

🏝️ Benefits

• Benefits Eligible.

• Paid Time Off programs.

• Health and welfare benefits including medical, dental, vision, life, and Short- and Long-Term Disability.

• Flexible Spending Accounts for qualifying health care and dependent care expenses.

• Family benefits such as adoption assistance and paid parental leave.

• Defined contribution retirement plans with employer match and various financial wellness programs.

• Educational Assistance Program.

• Competitive compensation.

• Programs that focus on career development.

• Potential for annual increases based on performance.

• Incentive pay for select roles.

• Premium pay opportunities such as shift, on-call, and more based on job responsibilities.