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Advocate Aurora Health

Regulatory Services Manager – NCCT

Advocate Aurora Health

. Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites .

Posted 4/29/2026full-timeRemote • North Carolina • 🇺🇸 United StatesMid-LevelSenior💰 $44,150 - $66,250 per yearWebsite

About the role

Key responsibilities & impact
  • Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites
  • Provides guidance and advice in the completion of initial and annual IRB approvals
  • Monitors the completion and approval of all IRB requests
  • Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract
  • Ensures that all HIPAA regulations, compliance and regulatory requirements are met
  • Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and all other regulations such as FDA, HHS, NIH, and OSHA
  • Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules
  • Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data
  • Assists principal investigators and project managers in developing progress reports and quality control monitoring
  • Establishes working relations with other departments and organizations and assists in integration of studies when appropriate

Requirements

What you’ll need
  • Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science
  • Three years of relevant management experience
  • Experience in medical/research environment preferred
  • Excellent verbal and written communication skills
  • Demonstrates knowledge of scientific and statistical principles
  • Ability to travel to affiliate sites, clinical sites and national meetings
  • Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices

Benefits

Comp & perks
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
IRB approvalsHIPAA complianceFDA regulationsHHS regulationsNIH regulationsOSHA regulationsdata analysisquality control monitoringclinical research managementGood Clinical Practices
Soft Skills
administrative directionguidance and advicecommunication skillsperformance evaluationsteam managementinterdepartmental relationsproblem-solvingorganizational skillsleadershipcollaboration
Certifications
Master's degree in Health AdministrationMaster's degree in NursingMaster's degree in BusinessMaster's degree in Basic Science