Urology San Antonio · 3 weeks ago
Research Quality Control Associate
San Antonio, TX
Full-time
Onsite
Mid Level
4+ years expUrology San Antonio is seeking a Research Quality Control Associate to oversee clinical monitoring activities related to Quality Control and compliance. The role involves ensuring protocol compliance, data accuracy, and patient safety, while collaborating with cross-functional 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
Required
Bachelor's degree in life sciences or related field required
Minimum 3 years of progressive experience in research management, monitoring, and/or quality required
Valid driver's license and insured automobile required
Quality assurance/control: 4 years (Required)
FDA regulations: 4 years (Required)
Knowledge of research methods and procedures sufficient to compile data and prepare reports
Knowledge of confidentiality requirements related to patient information
Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
Ability to learn and proficiently utilize diverse eCRF systems, electronic regulatory management systems, Electronic Medical Record systems (EMR)
Readiness to adapt new technology
Willingness to travel on-site as needed
Preferred
Certification in clinical research (e.g. ACRP or SOCRA)
Company
Urology San Antonio
Urology San Antonio is a group of over 200 caregivers dedicated to improving your urologic health and overall wellness.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Daniel Saltzstein
Urologist, Partner, Board Member
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