Talent.com
Clinical Research Quality Regulatory Coordinator

Clinical Research Quality Regulatory Coordinator

BVL Clinical ResearchLiberty, MO, United States
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.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 .

    serp_jobs.job_alerts.create_a_job

    Clinical Research Coordinator • Liberty, MO, United States

    Job_description.internal_linking.related_jobs
    Lab Analyst I

    Lab Analyst I

    ICONLenexa KCIB (PRA), Kansas, US
    serp_jobs.job_card.permanent
    Lab Analyst I- Full Time, Onsite- Lenexa, KS.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Epidemiologist

    Epidemiologist

    TradeJobsWorkForce64151 Kansas City, MO, US
    serp_jobs.job_card.full_time
    Plan and direct studies of public health problems to find ways to prevent and treat them if they arise Collect and analyze data—through observations, interviews, and surveys, and by using samples o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Program Coordinator

    Regulatory Program Coordinator

    Saint Luke's Health SystemKansas City, MO, US
    serp_jobs.job_card.full_time
    Manage, oversee and coordinate all activities related to maintaining an ongoing state of regulatory compliance through proactive risk assessments and mitigation efforts. Requires 3 to 5 years' work ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Quality Management Systems Coordinator

    Quality Management Systems Coordinator

    Martinrea International Inc.Riverside, MO, USA
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Martinrea is a diversified global automotive supplier, engaged in the design, development and manufacturing of metal parts, assemblies and modules, complex fluid management systems and aluminum pro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Clinical Research Coordinator

    Clinical Research Coordinator

    Civia HealthIndependence, MO, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Clinical Research Coordinator Location : .Independence, Missouri Job Type : Full-time, non-exempt Reports to : Executive Director, Head of Site Operations Join Us at Civia Heal...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Telemedicine Physician

    Telemedicine Physician

    QuickMDOak Grove, MO, US
    serp_jobs.job_card.full_time
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Lab Analyst 3

    Lab Analyst 3

    ICONLenexa KCIB (PRA), Kansas, US
    serp_jobs.job_card.permanent
    Lab Analyst 3- Lenexa, KS- Onsite; Full-Time.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Clinical Research Coordinator II

    Clinical Research Coordinator II

    ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATESKansas City, MO, US
    serp_jobs.job_card.full_time
    CLINICAL RESEARCH COORDINATOR II.The Clinical Research Coordinator (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance wi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Technologist

    Medical Technologist

    Centerpoint Medical CenterIndependence, MO, US
    serp_jobs.job_card.full_time +1
    Sign On Bonus for Qualified Candidates! Apply Now!.Experience the HCA Healthcare difference where colleagues are trusted, valued members of our healthcare team. Grow your career with an organization...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Entry Level Phlebotomist - Paid Training

    Entry Level Phlebotomist - Paid Training

    Biolife Plasma Services CareersIndependence, MO, US
    serp_jobs.job_card.part_time
    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Sr. Clinical Data Coordinator

    Sr. Clinical Data Coordinator

    TradeJobsWorkForce64150 Riverside, MO, US
    serp_jobs.job_card.full_time
    Clinical Data Coordinator Job Duties : Support laboratory data management procedures including authoring and reviewi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Springboard HealthcareLiberty, MO, US
    serp_jobs.job_card.full_time
    Springboard Healthcare is seeking a travel Cath Lab Technologist for a travel job in Liberty / MO, Missouri.Job Description & Requirements. Springboard Healthcare Job ID #789106.Pay package is ba...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Study Coordinator ll

    Study Coordinator ll

    Johnson County ClintrialsKansas City, MO, US
    serp_jobs.job_card.full_time
    Clinical Research Consultants (CRC).The Study Coordinator position is responsible for the coordination and administration of clinical studies under the direction of the Site Director, and the Princ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Laboratory Technician

    Medical Laboratory Technician

    TradeJobsWorkForce64150 Riverside, MO, US
    serp_jobs.job_card.full_time
    Receive, label and analyze samples (blood, toxic, tissue etc.Design and execute laboratory testing according standard procedures, make observations and interpret findings Conduct experiments under ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Manager, Quality Laboratories (Central Services)

    Senior Manager, Quality Laboratories (Central Services)

    AbbVieKansas City, MO, US
    serp_jobs.job_card.temporary
    Senior Manager, Quality Laboratories.AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Entry Level Phlebotomist – Paid Training

    Entry Level Phlebotomist – Paid Training

    Biolife Plasma Services CareersINDEPENDENCE, MO, United States
    serp_jobs.job_card.part_time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further attest th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    Phlebotomist I (#43626)

    Phlebotomist I (#43626)

    Quest DiagnosticsLiberty, Missouri, United States
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Day 1 Medical / Dental / Vision for FT employees who work 30+ hours.Tuition Reimbursement for undergraduate and graduate programs for FT employees who work 30+ hours. Opportunities for career advancemen...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Clinical Research Coordinator

    Clinical Research Coordinator

    BVL Clinical ResearchLiberty, MO, United States
    serp_jobs.job_card.full_time
    Our team partners with leading physicians, sponsors, and patients to advance innovative treatments that improve lives.Clinical Research Coordinator (CRC). This position is ideal for candidates with ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours