Regulatory Specialist

Job Title: Regulatory Specialist

Location: 100 First Street, Hackensack, NJ 07601

** First 90 days onsite. After 90 days hybrid schedule 3x a week on-site**

PR: $27-$37

Duration: 6 month contract ( extension or conversion)

Schedule: M-F: 9am-5:30pm

JOB DESCRIPTION

Insight Global is seeking a Regulatory Specialist with hands‑on clinical research site experience to join the Clinical Research team at Hackensack Meridian Health in Hackensack, NJ. This on‑site, 40‑hour‑per‑week contract role will support day‑to‑day site‑level regulatory operations for active clinical trials, ensuring compliance with institutional, federal, and sponsor requirements. On a daily basis, the Regulatory Specialist will prepare, submit, and manage IRB documentation including initial submissions, protocol amendments, continuing reviews, and informed consent updates; maintain complete and audit‑ready regulatory binders; track and manage essential documents within CTMS and document management systems; and serve as a primary regulatory point of contact for PIs, study teams, sponsors, CROs, and IRBs. The role also involves supporting protocol activation and ongoing study maintenance, preparing for and assisting with site audits, inspections, and monitoring visits, addressing regulatory findings through corrective and preventive actions, and managing multiple studies simultaneously in a fast‑paced clinical research environment while ensuring ongoing compliance with FDA regulations, ICH‑GCP guidelines, and institutional policies.

MUST‑HAVE REQUIREMENTS

• Bachelor’s degree in life sciences or a related field (Master’s preferred)
• Local IRB submission and submitting by themselves
• Minimum 2–3 years of hands‑on clinical research site regulatory experience
• Direct experience with the IRB lifecycle at the site level, including:
• Local IRB submissions
• Informed consent documents
• Continuing reviews
• Protocol amendments
• Strong working knowledge of:
• IRB processes
• FDA regulations
• GCP guidelines
• Proficiency with CTMS and regulatory document management systems
• Strong organizational and communication skills
• Proven ability to manage multiple studies and deadlines in a fast‑paced research environment
• On‑site availability required (no remote or hybrid)

$27 to $37

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.