Regulatory Specialist

Overview

Job Title:
Regulatory Specialist

The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. This role serves as a liaison to investigators, collaborating divisions, departments, institutions, the Institutional Review Board (IRB), and external regulatory agencies.

• Organize and maintain the regulatory binder, file essential documents, and obtain signatures for delegation logs, training logs, and other essential study documents.
• Review sponsor templates and site-level Informed Consent Forms (ICF) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
• Participate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), and Investigational New Drug (IND) applications.
• Ensure timely and accurate submission of all protocol amendments, ICFs, Investigator Brochures, and other administrative items to the IRB of record.
• Arrange for receipt and transmission of administrative and regulatory documents, and file Serious Adverse Event (SAE) and IND safety reports.
• Review and interpret IRB correspondence with the research team, notifying them of determinations affecting the safety and welfare of human subjects.
• Obtain and maintain updated lab/test ranges.
• Update electronic databases for any personnel changes.
• Act as a liaison between investigators, sponsors, and the IRB on all regulatory issues.
• Assist investigators in obtaining necessary access to facilitate research readiness.
• Provide timely follow-up, issue resolution, update reports, and escalate problems as necessary.
• Attend and actively participate in study team meetings, sponsor meetings, research meetings, and conferences/in-service education sessions.
• Prepare the regulatory binder for monitor visits, audits, or site inspections.
• Perform other work-related duties as assigned.
• Assist with orienting new staff on their regulatory responsibilities.
• Serve as a resource for questions related to regulations affecting clinical research.
• Stay updated on developments in GCP and federal regulations regarding clinical research.
• Maintain overall awareness in the field of clinical research by reading related literature, attending training classes, and professional meetings.
• Assist in developing procedures to ensure regulatory compliance.

• Clinical trial regulatory experience, particularly dealing with IRB and maintaining components of clinical trial conduct.
• BA/BS degree in science/health care or communication field, or equivalent related education and experience.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational, presentation, documentation, and interpersonal skills.
• Ability to work independently or in a team, handling multiple deadline-driven tasks in a dynamic environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
• Review and comply with all relevant policies, procedures, and laws.

• Minimum 3 years of experience in the field or in a related area.
• Mandatory education on human subject research and GCP.
• Knowledge of clinical trials.
• Familiarity with basic scientific principles.
• Ability to work in a fast-paced environment and manage competing tasks and demands.

This is a hybrid role, requiring 3 days on-site and 2 days remote, with non-consecutive remote days. The environment is supportive and collaborative, offering opportunities for career progression.

This is a Contract to Hire position based out of Hackensack, NJ.

The pay range for this position is $30.00 - $35.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision;
Critical Illness, Accident, and Hospital; 401(k) Retirement Plan –…