QA/QC Specialist - 258803

Medix™; Miami (FL); On-site; USD 65,000 - 85,000; Full time

Job summary

Medix in Doral, FL is seeking a meticulous QA/QC Specialist to join the Quality team. You will perform QA/QC reviews of clinical trial regulatory files, source documents, and data entry, supporting our transition from paper to eSource technology.

The role involves internal audits to ensure GCP, FDA, and protocol compliance, travel to Pembroke Pines and Lauderdale Lakes, and collaboration with CRCs and Site Directors to implement CAPA plans.

Qualifications

• 1–3 years in clinical trial QA/Regulatory compliance or QC.
• Experience with E-Reg, eSource, CTMS, and major EDC systems (MediData Rave, REDCap preferred).
• Valid driver’s license and reliable transportation to visit satellite sites.

Responsibilities

• Quality auditing of participant charts, informed consent forms, regulatory binders, and investigator site files to ensure GCP, FDA, and protocol compliance.
• Assist in implementing eSource workflows across facilities, reviewing paper to digital documentation to prevent data discrepancies.
• Travel to Pembroke Pines and Lauderdale Lakes to conduct routine QA reviews and support audit preparation.

Skills

Quality Assurance

Quality Control

GCP

FDA compliance

Regulatory compliance

Auditing

Travel readiness

Tools

MediData Rave

REDCap

CTMS

eSource

E-Reg

Job description

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

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

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

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

About the Role

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.

Key Responsibilities

• 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.
• 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).

Qualifications & Preferred Experience

• 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.