Job Description
QA/QC Specialist (Regional / Base Site: Doral, FL)
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Position: Quality Assurance / Quality Control (QA/QC) Specialist
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Location: Base at Doral, FL (Main Site) with travel to Pembroke Pines & Lauderdale Lakes as needed
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Mileage Reimbursement: Standard government rate provided for site-to-site travel outside base
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About the Role
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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.
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Key Responsibilities
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- 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.
- eSource Transition Support: Assist in implementing eSource workflows across all facilities, reviewing dual-system documentation (paper to digital) to prevent data discrepancies.
- Multi-Site Auditing: Travel to secondary clinic sites (Pembroke Pines and Lauderdale Lakes) to conduct routine QA reviews and support audit preparation.
- Corrective Actions: Work alongside CRCs and Site Directors to identify documentation trends, log query trends, and implement Corrective and Preventive Action (CAPA) plans.
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Schedule & Site Expectations
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- Work Arrangement: Onsite with multi-site travel flexibility. Occasional weekend/Saturday support as audit timelines require.
- Dress Code: Solid Black Scrubs (Doral/Pembroke Pines) or Dark Green Scrubs (Lauderdale Lakes when visiting).
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Qualifications & Preferred Experience
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- Clinical Research QA Experience: 1–3 years in clinical trial monitoring, regulatory compliance, or quality control.
- Systems Proficiency: Experience with E-Reg, eSource, CTMS, and major EDC systems (MediData Rave and REDCap preferred).
- Travel: Must have a valid driver’s license and reliable transportation to visit satellite sites.
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Hiring Process
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- First Round: Remote Video Interview
- Second Round: Onsite Interview
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