Quality Control Coordinator

Job Description

Quality Control Coordinator | Johnson County Clin Trials (JCCT)

The Tone:
This is a full-time role at Johnson County Clin Trials (JCCT), located in Johnson County. JCCT is dedicated to advancing healthcare through meticulously conducted clinical research studies. This Quality Control Coordinator position plays a vital role in ensuring the scientific integrity and regulatory compliance of all clinical trials. By meticulously verifying data accuracy and adherence to established protocols, this role directly contributes to the reliability of research outcomes and the safety and well-being of study volunteers, upholding the company’s commitment to ethical and high-quality research.

The TL;DR
• Role: Early Career
• Type: Full-time
• Location: In-person, Johnson County

• Team: Part of the Operations department, collaborating with clinical research teams.
• Mission: To serve as a subject matter expert in clinical research policies and procedures by verifying information accuracy on volunteer charts and ensuring overall study compliance.
• Tech Stack: Microsoft Office Suite, Clinical Conductor, clinical trial management system software

What You’ll Actually Do
• Data Quality Assurance: Meticulously review study data captured in volunteer study binders and other source documentation, including intake forms, medical histories, lab results, and adverse event reports, to ensure real-time compliance with protocols and sponsor requirements while volunteers are on-site.
• Discrepancy Resolution & Training: Identify and manage discrepant data capture, verifying appropriate corrections are made through confident, knowledge-based conversations with clinic staff, investigators, and volunteers, and providing real-time education to prevent future errors.
• Regulatory Compliance: Verify volunteer safety and ensure strict adherence to all FDA regulations, ALCOA-C principles, ICH/GCP guidelines, and specific protocol requirements for the duration of trials, ensuring ethical and compliant research practices.
• Operational Oversight: Conduct source-data verification of volunteer eligibility prior to randomization or baseline visits, ensure accurate completion of visits in Clinical Conductor for payment allocation and scheduling, and prepare the site for monitoring visits, FDA audits, and sponsor audits.
• Expert Resource & Collaboration: Serve as a subject matter expert in clinical research policies and procedures, actively collaborating with site investigators, clinical research coordinators, and other staff to ensure all protocol guidelines are completed appropriately and to maintain QA department metrics.

The Must-Haves
• Background: Possess a high school diploma or GED, with a preferred college-level education. Must have a basic understanding of regulations governing clinical research, including CFR, GCP, and HIPAA guidelines.
• Experience: Demonstrated proficiency with Microsoft Office Suite and the Clinical Conductor system. Prior experience in a clinical research setting or a related work environment is preferred.
• Skills: Exhibit excellent written, verbal, and interpersonal communication skills for effective team collaboration and volunteer interaction. Possess strong knowledge of medical terminology and concepts relevant to clinical trials. Display exceptional detail orientation with the ability to perform at a high level of accuracy when reviewing complex data. Demonstrate robust analytical and problem-solving skills to identify and resolve data discrepancies.
• Bonus: A college-level degree is preferred, along with prior experience in a clinical research setting. Familiarity with, or the ability to quickly learn, clinical trial management system software will be highly valued.