Remote Regulatory Services Manager - Clinical Trials

Advocate Aurora Health; Wake Forest (NC); Remote; USD 61,000 - 91,000; Full time

Job summary

The Advocate Health National Center for Clinical Trials (NCCT) in Wake Forest is seeking a regulatory services leader to oversee IRB submissions, HIPAA compliance and regulatory operations across multiple trials. You will supervise staff, coordinate audits and ensure compliant, efficient trial processes.

Requires a Master's degree in Health Administration or related field with three years of management experience; strong knowledge of GCP, FDA, ICH and HIPAA regulations.

Qualifications

• Master's degree in Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience.
• Experience in medical/research environment preferred.

Responsibilities

• Provides administrative oversight and leadership to regulatory staff, including hiring, training, and performance management.
• Oversees regulatory submissions, IRB reviews, and study document management.
• Ensures compliance with GCP, FDA, ICH, HIPAA and institutional policies.
• Leads audits, CAPAs, and regulatory inspections and responses.
• Coordinates regulatory metrics and communicates status to investigators and leadership.

Skills

Excellent verbal and written

Regulatory knowledge

HIPAA compliance

IRB submissions

Regulatory audits

Communication with investigators

Travel to sites

Education

Master's degree in Health Administration

Job description

The Advocate Health National Center for Clinical Trials (NCCT) in Wake Forest is seeking a regulatory services leader to oversee IRB submissions, HIPAA compliance and regulatory operations across multiple trials. You will supervise staff, coordinate audits and ensure compliant, efficient trial processes.

Requires a Master's degree in Health Administration or related field with three years of management experience; strong knowledge of GCP, FDA, ICH and HIPAA regulations.