Remote Regulatory Services Lead - Clinical Trials

Atrium Health; Charlotte (NC); Remoto; USD 126.508.000 - 189.833.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid Time Off

Health benefits

Flexible spending accounts

Adoption assistance

Retirement plan with employer match

Educational assistance

Descrizione del lavoro

Advocate Health's National Center for Clinical Trials (NCCT) seeks a regulatory services leader to oversee IRB submissions, HIPAA compliance, and regulatory affairs across a large portfolio of clinical trials. You will supervise regulatory staff, coordinate audits, and drive policy implementation to maintain compliance.

Requires a Master's degree and 3+ years of regulatory management experience in a medical/research setting; strong communication and leadership skills are essential.

Competenze

• Master's degree with three years of relevant management experience; healthcare/research environment preferred.
• Excellent verbal and written communication skills.
• Familiar with institutional/government regulations and guidelines for clinical research (GCP, ICH, FDA, HIPAA).

Mansioni

• Provide administrative direction and coordination of Regulatory Services for NCCT clinical research.
• Oversee regulatory submissions and IRB reviews, amendments, reportable events and study closures.
• Ensure compliance with applicable regulations and standards across numerous trials.
• Lead audits/ inspections responses and CAPA plans.
• Monitor regulatory changes and implement process improvements.
• Coordinate regulatory metrics, reports and compliance analyses.
• Assist leadership in implementing regulatory policies and quality initiatives.
• Manage multiple regulatory projects and staff.
• Communicate status and risks to investigators and leadership.

Conoscenze

Verbal and written communication

Regulatory knowledge

Regulatory travel

GCP/ICH/FDA/HIPAA familiarity

Formazione

Master's degree in Health Admin / Nursing / Business / Basic Science

Descrizione del lavoro

Advocate Health's National Center for Clinical Trials (NCCT) seeks a regulatory services leader to oversee IRB submissions, HIPAA compliance, and regulatory affairs across a large portfolio of clinical trials. You will supervise regulatory staff, coordinate audits, and drive policy implementation to maintain compliance.

Requires a Master's degree and 3+ years of regulatory management experience in a medical/research setting; strong communication and leadership skills are essential.