Job Description

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

• Support and enhance the site’s Quality Management System (QMS).
• Conduct periodic internal audits of regulatory files, source documentation, and CRFs.
• Track and manage protocol deviations, noncompliance events, and CAPAs.
• Maintain inspection readiness across all active trials.

Study Start-Up Support

• Coordinate regulatory tasks related to site initiation and study start-up.
• Maintain investigator credentials, training logs, and required documentation (e.g., 1572, CVs, licenses).

Training & Oversight

• Ensure clinical staff maintain current GCP and protocol-specific training.
• Assist with onboarding and ongoing staff education on regulatory processes.
• Support sponsor and CRO monitoring visits and audits.

Documentation & Reporting

• Maintain version control and audit trails for all clinical and regulatory documents.
• Draft and update SOPs, logs (training, delegation, document tracking), and compliance reports.
• Provide regular regulatory status reports to site leadership.

Additional Responsibilities

• Contribute to protocol development and review for compliance.
• Support internal/external audits, inspections, and monitoring visits.
• Collaborate with PIs and study teams to ensure efficient trial execution.
• Comply with all policies, standards, mandatory training, and requirements of BVL Clinical Research.

Qualifications

Education

• Bachelor’s degree in Life Sciences, Healthcare, or a related field (required).
• Advanced training or certification in regulatory affairs or clinical quality (preferred).

Experience

• 2+ years in a clinical research environment, preferably at a private site or research clinic.
• Experience with IRB submissions, regulatory binders, and clinical research SOPs.

Skills & Knowledge

• Working knowledge of FDA regulations, ICH-GCP, HIPAA, and 21 CFR Part 11.
• Proficiency in Microsoft Office and electronic regulatory systems.
• Excellent organizational, communication, and multitasking abilities.

Preferred Certifications

• ACRP or SOCRA certification (CCRP, CCRC, or equivalent).
• GCP or Clinical Research Quality training/certification.

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:

• Hands-on experience with cutting-edge clinical trials in gastroenterology and hepatology.
• Opportunities for professional growth in regulatory affairs, quality assurance, and clinical operations.
• A supportive environment where your ideas and contributions truly matter.
• The chance to be part of meaningful research that directly impacts patient outcomes.

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.

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