Regulatory Specialist, Clinical Trials Compliance

Hackensack Meridian Health Inc.; West Grove (NJ); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Customer service focus

Communication

Organizational skills

Interpersonal skills

Microsoft Office

Google Suite

Ausbildung

BA/BS in science or healthcare field

2+ years of related experience with GED/HS

Tools

Microsoft Office Suite

Google Suite/Workspace

Jobbeschreibung

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