Regulatory Services Manager – National Center for Clinical Trials

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

📋 Description

• Provide comprehensive administrative leadership and coordination for Regulatory Services in NCCT clinical research.

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

• Supervise and mentor staff on IRB submissions, HIPAA compliance, and regulatory communications.

• Develop, implement, and uphold policies, procedures, and tools that support compliant research operations.

• Lead the hiring process, training, performance management, coaching, and professional development for regulatory personnel.

• Oversee IRB submissions and approvals, regulatory documentation, and the closure of studies.

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

• Manage audits and inspections, including addressing findings and developing CAPA plans.

• Oversee regulatory projects and workflows, including timelines, deliverables, risks, and resources.

• Communicate regulatory status and compliance matters to investigators, study teams, and leadership.

• Monitor regulatory changes and lead updates to related processes or policies.

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

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

• Prepare regulatory metrics, reports, and compliance analyses.

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

• Manage special regulatory projects and undertake related responsibilities.

⛳️ Requirements

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

• Experience in a medical or research setting is preferred.

• Exceptional verbal and written communication skills.

• Understanding of scientific and statistical principles.

• Ability to travel to affiliate sites, clinical locations, and national meetings.

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

• Knowledge of Good Clinical Practices.

🏝️ Benefits

• Comprehensive Total Rewards benefits and well-being programs.

• Competitive compensation.

• Generous retirement offerings.

• Career development programs.

• Premium pay options such as shift and on-call pay, based on eligibility.

• Incentive pay available for select positions.

• Opportunity for annual performance-based raises.

• Paid Time Off programs.

• Medical, dental, vision, life, and short- and long-term disability benefits.

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

• Adoption assistance.

• Paid parental leave.

• Defined contribution retirement plans with employer matching.

• Financial wellness programs.

• Educational Assistance Program.