QA/QC Specialist: Regional Clinical Trials & eSource

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

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.