Clinical Research Quality Regulatory Coordinator

Job Description

BVL Clinical Research is a dedicated clinical research site located in Liberty, Missouri, specializing in gastroenterology and hepatology. We are currently conducting multiple clinical trials focused on Crohn’s Disease and Ulcerative Colitis.

Position Overview

We're seeking an on-site Clinical Research Quality Regulatory Coordinator to support and oversee regulatory compliance and quality assurance activities across all clinical trials conducted at our site. This position ensures that studies are conducted in alignment with FDA regulations, GCP guidelines, sponsor requirements, and internal SOPs.

This role focuses on regulatory document management, quality oversight, and inspection readiness to support a high standard of clinical trial execution across all studies.

Please Note : This is a fully on-site position. Candidates must be located within commuting distance to Liberty, MO. Relocation assistance is not available.

Key Responsibilities

Regulatory Coordination

• Prepare, submit, and track IRB documents (initial submissions, amendments, continuing reviews, safety reports).
• Maintain complete and up-to-date regulatory binders and essential trial documents.
• Liaise with sponsors, CROs, IRBs, and regulatory authorities regarding document requests and compliance.
• Ensure timely filing of ICFs, protocol amendments, and safety updates.

Quality Assurance & Compliance

Study Start-Up Support

Training & Oversight

Documentation & Reporting

Additional Responsibilities

Qualifications

Education

Experience

Skills & Knowledge

Preferred Certifications

Why Join BVL Research?

At BVL, you'll be part of a passionate and collaborative team dedicated to advancing clinical care for patients with serious gastrointestinal conditions. We combine the integrity of research with the compassion of patient-centered care.

As a growing private site, we offer :

Join us in driving innovation, maintaining the highest standards in clinical research, and making a real difference in patients' lives.

Learn more at BVLResearch.com.