Regulatory Services Lead, Clinical Trials & Compliance

Wake Forest University School of Medicine; Allenton (WI); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Wake Forest University School of Medicine is seeking a Regulatory Services leader for the NCCT to oversee regulatory staff and ensure compliance across numerous clinical trials. The role focuses on IRB submissions, HIPAA compliance, audit readiness, and CAPA management, guiding policy implementation and improving research operations.

The position requires a Master’s degree in a relevant field and 3+ years of management experience in a medical/research environment, with travel to affiliate sites

Competenze

• Excellent verbal and written communication skills.
• Demonstrates knowledge of scientific and statistical principles.
• Ability to travel to affiliate sites, clinical sites and national meetings.
• Familiar with institutional/governmental regulations and guidelines related to clinical research including GCP.

Mansioni

• Provides overall administrative direction and coordination of Regulatory Services for NCCT.
• Oversees regulatory submissions and approvals, including IRB reviews, amendments, and study closures.
• Ensures compliance with applicable regulations (GCP, ICH, FDA, HIPAA, state/federal).
• Leads audit preparations and CAPA development and tracking.
• Manages multiple regulatory projects and timelines, allocating staff resources.
• Communicates regulatory status and risks to investigators, teams, and leadership.
• Keeps abreast of regulatory changes and implements policy/process updates.

Conoscenze

Excellent verbal and written comms

Knowledge of scientific & statistical

Travel to affiliate sites & national会议

Familiar with regulations (GCP/FDA/HIP

Formazione

Master's in Health Admin, Nursing, Business or Basic Science

Descrizione del lavoro

Wake Forest University School of Medicine is seeking a Regulatory Services leader for the NCCT to oversee regulatory staff and ensure compliance across numerous clinical trials. The role focuses on IRB submissions, HIPAA compliance, audit readiness, and CAPA management, guiding policy implementation and improving research operations.

The position requires a Master’s degree in a relevant field and 3+ years of management experience in a medical/research environment, with travel to affiliate sites