QA/QC Specialist - 258803

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