Regulatory Services Manager - Clinical Trials Compliance

Advocate Health; Winston-Salem (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Advocate Health's NCCT seeks an experienced Regulatory Services leader to provide administrative direction and oversee regulatory operations for numerous clinical trials, ensuring compliance with IRB, FDA, HIPAA and related regulations. The role leads regulatory staff, manages submissions, audits, CAPA responses, and implements policies to support compliant research.

Travel to affiliated sites and meetings may be required.

Qualifications

• 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 GCP and FDA requirements.

Responsibilities

• 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.
• Manages multiple regulatory projects and workflows, monitoring progress against timelines and deliverables and addressing risks or barriers.
• 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.

Skills

Verbal and written communication

Regulatory knowledge

Regulatory affairs leadership

Travel willingness

Education

Master's degree in Health Administration / Nursing / Business / Basic Science

Job description

Advocate Health's NCCT seeks an experienced Regulatory Services leader to provide administrative direction and oversee regulatory operations for numerous clinical trials, ensuring compliance with IRB, FDA, HIPAA and related regulations. The role leads regulatory staff, manages submissions, audits, CAPA responses, and implements policies to support compliant research.

Travel to affiliated sites and meetings may be required.