QUALITY CONTROL SPECIALIST
Clinical Trials
Doral, FL • Onsite • Full-Time • Monday to Friday
At Suncoast Research Associates, data quality is fundamental to patient safety and to the trust that leading pharmaceutical sponsors place in our work. We are seeking a Quality Control Specialist to ensure the accuracy and integrity of clinical data across our studies and to uphold the standards that keep our research reliable and inspection-ready.
About Suncoast Research Associates
Suncoast Research Associates is a privately owned clinical research organization established in 2018 in Doral, Florida. We partner with all major pharmaceutical companies and conduct studies across a wide range of therapeutic areas, helping patients access new treatments earlier while advancing the research that moves medicine forward. We do not offer remote work.
- Perform accurate and timely quality control review of clinical data across multiple concurrent studies and therapeutic areas within EDC, protecting data integrity from initial entry through database lock and meeting sponsor and study timelines.
- Review and interpret protocols, amendments, investigator brochures, and study manuals, and verify source documents and medical records with investigators and site staff to confirm compliance with protocol, GCP, and applicable regulatory standards.
- Identify, document, and escalate data discrepancies and deviations; support root cause analysis and corrective and preventive actions (CAPA); and analyze data trends to drive process improvement and enhance data quality.
- Support monitoring visits, audits, and inspections by maintaining comprehensive, accurate, and audit-ready documentation of QC activities, findings, and resolutions.
- Collaborate cross-functionally with coordinators, investigators, monitors, sponsors, CROs, and vendors to resolve data queries efficiently.
- Strong attention to detail with a consistent commitment to accuracy.
- Excellent organizational skills and the ability to manage competing priorities under deadline.
- Strong written and verbal communication skills.
- Proficiency in Excel, and the Microsoft Office suite (Word, Excel, PowerPoint).
- Previous experience in quality assurance or a related clinical research role is preferred.
- Meaningful work supporting studies that reach real patients.
- Exposure to leading pharmaceutical sponsors across a broad range of therapeutic areas.
- A collaborative team environment that values precision and accountability.
- Comprehensive benefits, including health, dental, vision, and life insurance, plus paid time off.
- Schedule: Monday to Friday, 8-hour shift.
- Location: Onsite in Doral, FL. Remote work is not available.
Qualified candidates who share our commitment to quality and integrity are encouraged to apply. Join us in advancing clinical research that patients and sponsors can trust.