Remote Regulatory Services Lead - Clinical Trials

Advocate Health; United States; Remote; USD 61,000 - 91,000; Full time

Benefits offered by this job

Health benefits

Job summary

Advocate Health National Center for Clinical Trials (NCCT) seeks an experienced regulatory services leader to supervise regulatory staff, coordinate IRB submissions, and ensure compliance with FDA, HIPAA, and ICH guidelines across a broad portfolio of clinical trials.

This role provides strategic direction, oversees audits and CAPA initiatives, and partners with investigators and stakeholders to maintain efficient workflows while upholding the highest standards of patient safety and research

Qualifications

• Master’s degree with 3+ years of management experience in medical/research environment preferred.
• Experience with clinical research regulations including FDA, ICH, HIPAA.
• Strong leadership and regulatory operations knowledge.

Responsibilities

• Provide administrative direction and coordination of Regulatory Services for NCCT.
• Oversee regulatory submissions and IRB reviews; ensure compliance across trials.
• Lead audits, CAPA plans, and regulatory metrics reporting.
• Develop and enforce regulatory policies and SOPs; manage staff development.
• Communicate risks and regulatory status to investigators and leadership.

Skills

Regulatory leadership

IRB submissions

GCP/HIPAA compliance

Regulatory guidance

Education

Master’s degree in Health Administration

Job description

Advocate Health National Center for Clinical Trials (NCCT) seeks an experienced regulatory services leader to supervise regulatory staff, coordinate IRB submissions, and ensure compliance with FDA, HIPAA, and ICH guidelines across a broad portfolio of clinical trials.

This role provides strategic direction, oversees audits and CAPA initiatives, and partners with investigators and stakeholders to maintain efficient workflows while upholding the highest standards of patient safety and research