Regulatory Services Lead - Clinical Trials (Remote)

Atrium Health Wake Forest Baptist; Milwaukee (WI); Remote; USD 92,000 - 138,000; Full time

Benefits offered by this job

Paid Time Off

Health benefits

Retirement plans

Educational Assistance

Job summary

Advocate Health is seeking a Regulatory Services Manager for the NCCT administration team in a remote-capable role. You will direct regulatory activities across clinical trials, ensuring compliance with IRB, FDA, HIPAA, and related guidelines.

The role emphasizes leadership, audit readiness, and strategic regulatory planning. Ideal candidates hold a Master’s in Health Administration or related field with 3 years of management experience in a medical/research setting, and are comfortable

Qualifications

• Master's degree in Health Administration or related field with at least 3 years of management experience; equivalent combination acceptable.
• Experience in medical/research environment preferred.
• Knowledge of GCP/ICH/FDA/OHRP regulations and HIPAA is required.

Responsibilities

• Provide administrative leadership to regulatory staff, including hiring, training, and performance management.
• Oversee regulatory submissions, IRB reviews, amendments, and study closures; ensure timely documentation.
• Ensure compliance with applicable regulations and standards across multiple trials.
• Lead audits and CAPA planning; coordinate regulatory metrics and reporting.
• Communicate regulatory status and risks to investigators and leadership; monitor changes in regulations.

Skills

Regulatory knowledge

Regulatory submissions

HIPAA / regulatory compliance

Excellent communication

Education

Master's degree in Health Administration or related field

Job description

Advocate Health is seeking a Regulatory Services Manager for the NCCT administration team in a remote-capable role. You will direct regulatory activities across clinical trials, ensuring compliance with IRB, FDA, HIPAA, and related guidelines.

The role emphasizes leadership, audit readiness, and strategic regulatory planning. Ideal candidates hold a Master’s in Health Administration or related field with 3 years of management experience in a medical/research setting, and are comfortable