Regulatory Coordinator II (Remote)

Overview

This role involves preparing and submitting protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), institutional IRBs, external IRBs, IACUC, and any research committee involved in the Pre-Award/Post-Award process. The Regulatory Coordinator II submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation related to regulatory requirements for clinical studies and trials.

Responsibilities

• Prepare and submit protocols and supporting documents to regulatory bodies involved in the research process.
• Submit continuations and amendments to maintain compliance with regulatory requirements and institutional policies.
• Respond to questions from IRB or IACUC regarding regulatory aspects of studies.
• Complete forms and generate reports necessary for regulatory compliance.
• Establish and maintain research files and documentation pertaining to regulatory requirements for clinical trials.
• Represent the research department during meetings with pharmaceutical company monitors.
• Collaborate closely with clinical trial coordinators, research staff, and investigators to ensure all regulatory documents are current.
• Attend research team meetings and provide updates on regulatory submissions and amendments.
• Participate in required training and education programs; may provide training to other personnel.
• May engage in centralized departmental or institutional activities.
• May plan and coordinate strategies to improve standard operating procedures related to regulatory affairs, including drafting SOPs and job aids.
• Identify quality and performance improvement opportunities and collaborate on action plans.
• Ensure compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Boards.
• Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines.
• Maintain strict patient confidentiality in compliance with HIPAA regulations and applicable laws.

Requirements

• Bachelor's degree.
• Minimum of 3 years of directly related experience in clinical research regulatory affairs.
• Experience preparing and submitting regulatory documents, managing IRB and/or IACUC submissions, maintaining study regulatory files.
• Knowledge of and compliance with FDA regulations, GCP guidelines, HIPAA, and institutional requirements.

Location and Work Arrangement

• This position is 100% remote.
• Applicants must reside and be authorized to work in one of the following states at the time of hire: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, or Georgia.