Regulatory Specialist

Overview

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Regulatory Specialist is responsible for ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures. This role will serve as a regulatory liaison to internal and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, Biosafety committees, Laboratory facilities, and external regulatory agencies. This role is the primary point of contact and is responsible for the scheduling, preparation for and facilitation of conduct of all internal and external audits as well as ensuring ongoing compliance of study-related documentation throughout the clinical trial lifecycle for all assigned clinical trials.