BVL Clinical Research · 5 hours ago
Clinical Research – Regulatory & Compliance Coordinator
Liberty, MO
Full-time
Onsite
Entry, Mid Level
2+ years expBVL Clinical Research is a dedicated clinical research site located in Liberty, Missouri, specializing in gastroenterology. They are 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 their site.
Research
Responsibilities
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
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
Coordinate regulatory tasks related to site initiation and study start-up
Maintain investigator credentials, training logs, and required documentation (e.g., 1572, CVs, licenses)
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
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
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
Qualification
Required
Bachelor's degree in Life Sciences, Healthcare, or a related field
2+ years in a clinical research environment, preferably at a private site or research clinic
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
Advanced training or certification in regulatory affairs or clinical quality
ACRP or SOCRA certification (CCRP, CCRC, or equivalent)
GCP or Clinical Research Quality training/certification
Benefits
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.
Company
BVL Clinical Research
BVL Clinical Research is a dedicated clinical research site located in the Midwest, specializing in studies in the fields of gastroenterology.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase