Regulatory Specialist

Hackensack Meridian Health Inc.; West Grove (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Hackensack Meridian Health seeks a Regulatory Specialist to ensure compliance with Federal, State, and Local regulations for clinical trials. The role serves as regulatory liaison to investigators, sponsors, IRBs, and regulatory bodies, coordinating audits and maintaining trial documents throughout the lifecycle.

The ideal candidate will have a science/healthcare degree (or equivalent experience), strong attention to detail, excellent communication, and proficiency with Microsoft Office or

Qualifications

• BA/BS in science or healthcare field or 2+ years of related experience with GED/HS.
• 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.
• Proficiency in Microsoft Office Suite and/or Google Suite platforms.

Responsibilities

• Ensure compliance with Federal, State, and Local regulations for all assigned clinical trials.
• Serve as regulatory liaison to internal and external investigators, sponsors, IRBs and regulators.
• Coordinate and facilitate audits and inspections.
• Maintain study-related documentation throughout the trial lifecycle.

Skills

Attention to detail

Customer service focus

Communication

Organizational skills

Interpersonal skills

Microsoft Office

Google Suite

Education

BA/BS in science or healthcare field

2+ years of related experience with GED/HS

Tools

Microsoft Office Suite

Google Suite/Workspace

Job description

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 as it relates to all regulatory aspects of assigned clinical trials conduct. 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 for all regulatory matters concerning all assigned clinical trials 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.

Education, Knowledge, Skills and Abilities Required:

• BA/BS diploma/degree in science or healthcare field OR minimum of 2 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs.
• 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.

Education, Knowledge, Skills and Abilities Preferred:

• Minimum of 2 or more years of extensive experience in research that includes Clinical Research, Regulatory, Auditing, and interactions with an IRB.
• Education on human subject research and GCP.

Licenses and Certifications Preferred:

• Certified Clinical Research Professional or Certified Clinical Research Coordinator or Society of Clinical Research Associates Certification.