Regulatory Operations Lead - Clinical Trials (Remote)

Hugh Chatham Health; Winston-Salem (NC); Remote; USD 6,075,000 - 9,092,000; Full time

Benefits offered by this job

Paid Time Off

Health benefits

Educational Assistance Program

Retirement plans with employer match

Job summary

Advocate Health NCCT National Center for Clinical Trials seeks a Regulatory Services leader to oversee regulatory staff, ensure compliance with IRB, HIPAA, and FDA requirements, and coordinate audits across multiple trials. This role emphasizes policy development, CAPA planning, and cross‑functional collaboration with researchers and leadership.

The position is full-time with 40 hours weekly and allows remote work, requiring strong communication and regulatory expertise to maintain high

Qualifications

• Excellent verbal and written communication skills.
• Familiar with institutional/government regulations and guidelines related to clinical research including GCP, ICH, FDA, HIPAA.
• Ability to travel to affiliate sites, clinical sites and national meetings.
• Experience managing regulatory staff and coordinating audits.

Responsibilities

• Provides administrative oversight and direct leadership to regulatory staff, including hiring, training, performance management, coaching, and professional development.
• Oversees regulatory submissions and approvals, including IRB reviews, amendments, and study closures; monitors regulatory documentation.
• Ensures compliance with GCP, FDA, HIPAA, and other regulations; reviews policies and SOPs.
• Leads responses to audits and CAPA plans; coordinates regulatory metrics and reports; identifies trends for process improvement.

Skills

Verbal communication

Written communication

Regulatory knowledge

Travel willingness

Education

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

Job description

Advocate Health NCCT National Center for Clinical Trials seeks a Regulatory Services leader to oversee regulatory staff, ensure compliance with IRB, HIPAA, and FDA requirements, and coordinate audits across multiple trials. This role emphasizes policy development, CAPA planning, and cross‑functional collaboration with researchers and leadership.

The position is full-time with 40 hours weekly and allows remote work, requiring strong communication and regulatory expertise to maintain high