Regulatory Programs Lead - Clinical Trials

600 Advocate Health, Inc.; Winston-Salem (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits eligible

40 hours per week

Job summary

Advocate Health National Center for Clinical Trials (NCCT) is seeking a senior Regulatory Services leader to provide administrative direction and coordination across regulatory operations for a large portfolio of clinical trials.

Role focuses on overseeing regulatory staff, ensuring compliance with GCP/FDA/HIPAA, and coordinating regulatory submissions, audits, and quality initiatives. Requires a Master’s-level degree and management experience.

Qualifications

• Master's degree in a relevant discipline with three years of management experience; or an equivalent combination of education and experience.
• Experience in medical/research environment preferred.
• Familiar with Good Clinical Practices (GCP), FDA, and HIPAA regulatory requirements.

Responsibilities

• Provides administrative oversight and leadership to regulatory staff, including hiring, training, performance management, coaching, and development.
• Oversees regulatory submissions and approvals, including IRB reviews, amendments, reportable events, and study closures; ensures timely documentation.
• Leads preparation for audits and inspections; coordinates CAPA plans and responses to findings.
• Manages multiple regulatory projects and workflows; monitors progress against timelines and deliverables.
• Communicates regulatory status and risks to investigators, study teams, and leadership; escalates issues as needed.
• Keeps abreast of regulatory changes and implements process changes to maintain compliance.

Skills

Regulatory leadership

Regulatory compliance

IRB/HIPAA knowledge

Regulatory communication

Education

Master's degree in Health Administration, Nursing, Business, or Basic Science

3 years of management experience

Job description

Advocate Health National Center for Clinical Trials (NCCT) is seeking a senior Regulatory Services leader to provide administrative direction and coordination across regulatory operations for a large portfolio of clinical trials.

Role focuses on overseeing regulatory staff, ensuring compliance with GCP/FDA/HIPAA, and coordinating regulatory submissions, audits, and quality initiatives. Requires a Master’s-level degree and management experience.