Start Date: As soon as possible

Pay: $28.00/hr to $38.00/hr

Job Overview

We seek a Research Regulatory Coordinator (RRC) to support the regulatory aspects of clinical trials for the Research Institute. This position ensures clinical studies comply with federal regulations, institutional guidelines, and ethical standards. The RRC will independently prepare regulatory submissions, communicate with Institutional Review Boards (IRBs), and liaise between investigators, sponsors, and federal agencies. This full-time remote position is ideal for a detail-driven, experienced professional familiar with human subject research, clinical trial compliance, and regulatory documentation.

Schedule and Shift:

• Monday to Friday - 8:30 am - 5:00 pm
• Full-time
• Remote
• Assignment Length: 12 weeks

Primary Job Responsibilities:

• Coordinate and manage all regulatory submissions related to clinical trials, including IRB submissions, protocol amendments, renewals, adverse events, deviations, and study closures
• Prepare and maintain regulatory binders, informed consent forms, documentation logs, and study files in compliance with institutional and federal standards.
• Ensure accurate and timely communication with internal departments, IRBs, and sponsors, including the FDA and other regulatory bodies.
• Maintain compliance with all applicable federal regulations, institutional policies, and SOPs governing human subject research.
• Track and report the status of regulatory submissions and approvals
• Facilitate communication with National Clinical Trials Network (NCTN) groups, pharmaceutical sponsors, CROs, and other research stakeholders
• Act as liaison for audits and monitor visits, ensuring that documentation and study conduct are inspection-ready
• Monitor and maintain study timelines, alerting teams of deadlines and ensuring ongoing compliance
• Thorough knowledge of federal regulatory requirements for clinical trials, including GCP, FDA regulations, and IRB/ethics review processes
• Familiarity with IND, IDE, and other regulatory submissions
• Strong organizational skills with meticulous attention to documentation and file management
• Excellent communication skills, both written and verbal, to collaborate effectively with cross-functional teams and external agencies
• Ability to prioritize, multitask, and manage timelines in a fast-paced research environment
• Demonstrated ability to work independently, solve problems, and apply regulatory knowledge to real-time scenarios
• Technically proficient in MS Office, regulatory databases, electronic IRB platforms, and document tracking systems
• Thorough knowledge of federal regulatory requirements for clinical trials, including GCP, FDA regulations, and IRB/ethics review processes
• Familiarity with IND, IDE, and other regulatory submissions
• Excellent communication skills, both written and verbal, to collaborate effectively with cross-functional teams and external agencies
• Ability to prioritize, multitask, and manage timelines in a fast-paced research environment
• Demonstrated ability to work independently, solve problems, and apply regulatory knowledge to real-time scenarios
• Strong organizational skills with meticulous attention to documentation and file management
• Technically proficient in MS Office, regulatory databases, electronic IRB platforms, and document tracking systems

Qualifications:

• Bachelor’s Degree in a health science, life science, or regulatory-related field
• OR 3+ years of equivalent experience in clinical research or regulatory affairs
• 3–5 years of related work experience in clinical research, preferably with regulatory responsibilities
• Previous experience managing IRB submissions and sponsor communications required
• SOCRA or ACRP certification (Preferred Certifications)
• CITI Program training in Human Subjects Research (Preferred Certifications)

Benefits:

• Health, Dental, and Vision
• 401K