QA/QC Specialist - 258803

Job Description

QA/QC Specialist (Regional / Base Site: Doral, FL)

\n

\n

Position: Quality Assurance / Quality Control (QA/QC) Specialist

\n

\n

Location: Base at Doral, FL (Main Site) with travel to Pembroke Pines & Lauderdale Lakes as needed

\n

\n

Mileage Reimbursement : Standard government rate provided for site-to-site travel outside base

\n

\n

About the Role

\n

We are seeking an meticulous QA/QC Specialist to join our growing Quality team at our main Doral facility (team of 4+). In this critical role, you will perform quality control reviews of clinical trial regulatory files, source documents, and data entry across our portfolio of studies (including GLP-1, Asthma, and PCOS). A key focus of this position will be supporting our ongoing site transition from paper source documentation to eSource technology.

\n

\n

Key Responsibilities

\n

\n
• Quality Auditing: Conduct regular internal audits of participant charts, informed consent forms, regulatory binders, and investigator site files to ensure GCP, FDA, and protocol compliance.
\n
• eSource Transition Support: Assist in implementing eSource workflows across all facilities, reviewing dual-system documentation (paper to digital) to prevent data discrepancies.
\n
• Multi-Site Auditing: Travel to secondary clinic sites (Pembroke Pines and Lauderdale Lakes) to conduct routine QA reviews and support audit preparation.
\n
• Corrective Actions: Work alongside CRCs and Site Directors to identify documentation trends, log query trends, and implement Corrective and Preventive Action (CAPA) plans.
\n

\n

\n

Schedule & Site Expectations

\n

\n
• Work Arrangement: Onsite with multi-site travel flexibility. Occasional weekend/Saturday support as audit timelines require.
\n
• Dress Code: Solid Black Scrubs (Doral/Pembroke Pines) or Dark Green Scrubs (Lauderdale Lakes when visiting).
\n

\n

\n

Qualifications & Preferred Experience

\n

\n
• Clinical Research QA Experience: 1–3 years in clinical trial monitoring, regulatory compliance, or quality control.
\n
• Systems Proficiency: Experience with E-Reg, eSource, CTMS, and major EDC systems ( MediData Rave and REDCap preferred).
\n
• Travel: Must have a valid driver’s license and reliable transportation to visit satellite sites.
\n

\n

\n

Hiring Process

\n

\n
1. First Round: Remote Video Interview
\n
2. Second Round: Onsite Interview
\n

\n