We are seeking a detail-driven Quality Control (QC) Specialist to support clinical trial operations with a primary focus on pre-randomization quality control and patient eligibility review. This role is responsible for reviewing screened subjects to ensure strict compliance with protocol inclusion and exclusion criteria, Good Clinical Practice (GCP), regulatory requirements, and company SOPs prior to randomization. The QC Specialist plays a critical role in protecting data integrity, patient safety, and study compliance across multiple clinical trials. Key Responsibilities Perform pre-randomization QC review of screened patients to confirm protocol eligibility Verify inclusion and exclusion criteria using source documents, EDC, and study records Ensure accuracy, completeness, and consistency of screening data prior to randomization Identify, document, and escalate protocol deviations, eligibility issues, and data discrepancies Collaborate with Clinical Research Coordinators, Investigators, and Operations teams to resolve QC findings Maintain QC tracking logs and documentation to support audit readiness Support Sponsor and FDA audits, monitoring visits, and study inspections Ensure proper documentation and follow-up of corrective and preventive actions (CAPA) Participate in study initiation visits and other study-related meetings as applicable Stay current on

GCP, ICH, FDA

regulations, and clinical research best practices Required Qualifications Bachelor's degree in science or a related field 2-3 years of experience in clinical research, quality control, or quality assurance Strong understanding of clinical trial protocols, eligibility criteria, and pre-randomization workflows Working knowledge of

GCP, FDA

regulations, and clinical research compliance Excellent attention to detail, documentation, and organizational skills Strong analytical, problem-solving, and communication abilities Ability to work independently in a fast-paced clinical research environment Knowledge of medical terminology Preferred Qualifications Experience reviewing screening data and eligibility prior to randomization Familiarity with EDC systems and source document verification Prior experience supporting Sponsor or FDA audits Compensation & Benefits Competitive salary: $50,000 - $55,000 annually Health, dental, and vision insurance Paid time off and paid holidays Opportunities for growth within clinical research quality and operations

Job Type:

Full-time Pay:

$50,000.00 - $60,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person