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Urology San Antonio · 3 weeks ago

Research Quality Control Associate

San Antonio, TX

Full-time

Onsite

Mid Level

3+ years exp

Urology San Antonio is seeking a Research Quality Control Associate who will be responsible for clinical monitoring activities involving Quality Control and compliance. The role includes conducting quality control activities, reporting findings, collaborating with teams, and assisting with audits and inspections.

Health CareHealth Diagnostics

Responsibilities

Conduct internal quality control activities, as an internal monitor, to ensure protocol compliance, data accuracy, and patient safety, in compliance with Sponsor protocols, Good Clinical Practices (GCPs), standard operating procedures (SOPs), and applicable agency regulations

Report findings to QC and Research leadership and coordinate approved action items for process improvement

Collaborate with cross-functional teams to ensure timely completion of study milestones and deliverables

Contribute to the preparation of Quality reports and presentations for internal stakeholders

Assist the research staff in preparation of sponsors’ audits and Food and Drug Administration inspections

May assist with Corrective and Preventive Action (CAPA) plan resolutions as needed

Stay current with developments in clinical research regulations, guidelines, and industry best practices

Perform other related duties as assigned

Qualification

Quality assurance/controlFDA regulationsClinical research certificationClinical Practice (GCP)Research methods knowledgeECRF systems proficiencyConfidentiality requirements knowledgeSoft skills