Clinical Research, Internal Quality Assurance Associate
$150,000–$180,000 year
On-sitePhoenix, Arizona, United States
Job Summary
Implement and continuously improve the Quality Management System (QMS) by collaborating with Clinical Research, Quality, and Training teams to develop and maintain Standard Operating Procedures (SOPs) and controlled documents. Manage document control and Learning Management System (LMS) processes while assisting with internal and external audits and regulatory inspections. Ensure compliance with CSTL policies, Good Clinical Practice (GCP), and applicable regulatory requirements to promote quality and maintain the integrity of clinical research activities and human subject protections. Requires an associate degree, two years of clinical quality assurance experience, and proficiency in Microsoft Office. Monday-Friday, 40 hours per week, exempt position in Phoenix, AZ.
Required Qualifications
- Associate degree in related field
- Minimum of 2 years of proven experience in clinical quality assurance, training, compliance, regulatory, or a related role
- A minimum of 2 years in clinical research
- Fundamental understanding of medical/therapeutic area knowledge and medical terminology
- Highly skilled in Microsoft Office, proficiency in Microsoft Word and Excel, and the ability to learn appropriate software
- All candidates must be legally authorized to work in the United States
- Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas
Desired Qualifications
- Bachelor's degree in related field or demonstrated experience as evidence of competency
- Previous experience with complex, global trials
- Competent in study development processes, current industry standards, such as, but not limited to: ICH GCP, ISO 14155, IDE requirements, HIPAA, GDPR guidelines, Quality Management Systems, and 21 CFR Part 11 guidelines
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