Regulatory Specialist

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.

• BA/BS degree in the science/health care field or 2 years related experience.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational, presentation, documentation, and interpersonal skills.
• Ability to work independently, and in a team, and handle multiple deadline driven tasks in a dynamic environment is essential
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and/or Google Suite platforms.

• Minimum of 2 years experience in Clinical Research, Regulatory, Auditing or IRB.
• Mandatory education on human subject research and GCP.
• Knowledge of clinical trials.
• Familiarity with basic scientific principles and terminology.
• Ability to work in a fast-paced environment and manage competing tasks and demands.

• Certified Clinical Research Professional/CCRP or Certified Clinical Research Associate/CCRA or Certified Clinical Research Coordinator/CCRC or Society of Clinical Research Associates Certification/SoCRA.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!