Quality Control - Clinical Research

Suncoast Research Associates, LLC; Florida; On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Job summary

Suncoast Research Associates, LLC in Doral, Florida, seeks a Quality Control Specialist to ensure the accuracy and integrity of clinical data across multiple studies. You will uphold regulatory standards and support sponsor timelines while contributing to a trusted, inspection-ready research environment.

Key responsibilities include QC review across therapeutic areas, protocol interpretation, and cross-functional collaboration to resolve data queries.

Qualifications

• 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.
• Previous experience in quality assurance or a related clinical research role is preferred.

Responsibilities

• Perform accurate and timely quality control review of clinical data across studies and therapeutic areas.
• Review and interpret protocols, amendments, and study manuals; verify source documents for protocol compliance.
• Identify, document, and escalate data quality issues as needed.
• Support monitoring visits, audits, and inspections with audit-ready QC documentation.
• Collaborate cross-functionally with coordinators, investigators, monitors, sponsors, CROs, and vendors to resolve data queries.

Skills

Attention to detail

Organizational skills

Communication skills

Excel

Clinical data QA

GCP knowledge

Tools

EDC systems

Microsoft Office

Job description

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.

Key Responsibilities

• 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 escal
• 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.

Qualifications

• 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.

What We Offer

• 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.