Regulatory Programs Lead - Clinical Trials (Remote)

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

Benefits offered by this job

Remote work

Job summary

Advocate Health NCCT seeks an experienced regulatory leader to direct the Regulatory Services for the National Center for Clinical Trials. You will ensure compliance with IRB, HIPAA, and applicable regulations across a large portfolio of trials.

You will supervise regulatory staff, manage audits, and drive policy implementation to support compliant and efficient research operations. This role is based in the United States and offers a remote-friendly schedule.

Qualifications

• Master's degree in Health Administration, Nursing, Business, or a related field with at least three years of management experience.
• Experience in medical or research environments preferred.
• Ability to travel to affiliate sites, clinical sites and national meetings.

Responsibilities

• Provide administrative oversight and direct leadership to regulatory staff, including hiring, training, performance management, coaching, and remote training.
• Oversee regulatory submissions and approvals including IRB reviews and study closures; maintain regulatory documentation.
• Ensure all activities comply with GCP, ICH, FDA, OHRP, HIPAA, and departmental SOPs.
• Prepare for audits; lead CAPA responses and track corrective actions.
• Coordinate multiple regulatory projects and monitor timelines and deliverables.

Skills

Communication skills

Scientific principles

Travel readiness

Regulatory knowledge

Education

Master's degree in Health Administration / Nursing / Business

Job description

Advocate Health NCCT seeks an experienced regulatory leader to direct the Regulatory Services for the National Center for Clinical Trials. You will ensure compliance with IRB, HIPAA, and applicable regulations across a large portfolio of trials.

You will supervise regulatory staff, manage audits, and drive policy implementation to support compliant and efficient research operations. This role is based in the United States and offers a remote-friendly schedule.