Regulatory Services Manager – National Center for Clinical Trials

Advocate Aurora Health

. Provide overall administrative direction and coordination of Regulatory Services for NCCT clinical research .

Posted 10/26/2026full-timeRemote • North Carolina • United StatesMid-LevelSenior💰 $44 - $66 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance, including GCP, ICH, FDA, and HIPAA, while effectively managing regulatory staff and overseeing clinical research operations. Strong communication skills facilitate collaboration with stakeholders and ensure adherence to institutional and federal regulations.

Highest-signal resume keywords

Regulatory Compliance ManagementIRB Submission OversightGood Clinical Practices (GCP)Staff Supervision and DevelopmentRegulatory Documentation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceIRB SubmissionsGood Clinical Practices (GCP)Statistical PrinciplesRegulatory DocumentationPolicy DevelopmentAudit ManagementCAPA PlansClinical Research OperationsPerformance Management

Soft Skills

Excellent Communication SkillsLeadershipCoachingTeam CollaborationProblem-Solving

Industry Keywords

Clinical TrialsHIPAA ComplianceOHRP RegulationsInstitutional PoliciesFederal RegulationsResearch ComplianceStakeholder ManagementRegulatory AffairsClinical Research EnvironmentPerformance Metrics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide overall administrative direction and coordination of Regulatory Services for NCCT clinical research
Ensure compliance with institutional, IRB, federal, and other applicable regulatory requirements across clinical trials
Supervise and guide staff on IRB submissions, HIPAA compliance, and regulatory communications
Develop, implement, and enforce policies, procedures, and tools supporting compliant research operations
Lead hiring, training, performance management, coaching, and professional development for regulatory staff
Oversee IRB submissions and approvals, regulatory documentation, and study closures
Ensure compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and SOPs
Manage audits and inspections, including responses to findings and CAPA plans
Oversee regulatory projects and workflows, timelines, deliverables, risks, and resources
Communicate regulatory status and compliance issues to investigators, study teams, and leadership
Monitor regulatory changes and lead related process or policy updates
Support protocol development, study start-up, 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 perform related duties

Requirements

What you’ll need

Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or an equivalent combination of education and experience
Experience in a medical/research environment preferred
Excellent verbal and written communication skills
Knowledge of scientific and statistical principles
Ability to travel to affiliate sites, clinical sites, and national meetings
Familiarity with institutional and governmental regulations and guidelines related to clinical research
Knowledge of Good Clinical Practices

Benefits

Comp & perks

Comprehensive Total Rewards benefits and well-being programs
Competitive compensation
Generous retirement offerings
Career development programs
Premium pay such as shift and on-call pay, based on eligibility
Incentive pay for select positions
Opportunity for annual performance-based increases
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 match
Financial wellness programs
Educational Assistance Program