Regulatory Services Manager - NCCT (Remote)

Pay Range

• Provides administrative oversight and direct leadership to regulatory staff, including hiring, training, performance management, coaching, and professional development; supports remote training and ongoing regulatory education.
• Oversees regulatory submissions and approvals, including initial and continuing IRB reviews, amendments, reportable events, and study closures; monitors timely completion and maintenance of regulatory documentation.
• Ensures all regulatory activities are conducted in compliance with applicable regulations and standards, including GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and departmental SOPs.
• Prepares for, manages and responds to internal and external audits and inspections; leads responses to audit findings and coordinates development, implementation, and tracking of corrective and preventive action (CAPA) plans.
• Provides oversight of multiple regulatory projects and workflows, monitoring progress against timelines and deliverables and addressing risks or barriers.
• Allocates regulatory staff resources appropriately to support study portfolios and departmental priorities.
• Communicates regulatory status, risks, and potential compliance issues to investigators, study teams, and leadership; escalates concerns as appropriate.
• Monitors regulatory changes and guidance (e.g., FDA, NIH, HHS, HIPAA) and evaluates impact on clinical research operations; leads implementation of process or policy changes to maintain compliance.
• Supports protocol development and study start‑up and close‑out activities by advising on regulatory feasibility, documentation requirements, and transitions as funding or study status changes.
• Establishes and maintains effective working relationships with institutional stakeholders, sponsors, IRB, and regulatory agencies to support compliant research conduct.
• Coordinates preparation of regulatory metrics, reports and compliance analyses, identifying trends, risks, and opportunities for process improvement.
• Participates in departmental, institutional, and external meetings or committees related to research compliance and regulatory affairs.
• Assists leadership in implementing institutional and departmental regulatory policies and quality initiatives.
• Manages special regulatory projects and performs other related duties as assigned.

• 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

Our Commitment to You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training

• Premium pay such as shift, on call, and more based on a teammate's job

• Incentive pay for select positions

• Opportunity for annual increases based on performance

Benefits and more

• 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

Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.