QA Auditor II- remote anywhere in the US!
Employer Industry: Clinical Research
Why Consider This Job Opportunity
Opportunity for career advancement and growth within the organization
Competitive salary with potential bonuses
Supportive and collaborative work environment
Chance to make a significant impact on the quality and integrity of clinical research programs
Opportunities for professional development through mentoring and training
What To Expect (Job Responsibilities)
Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes and regulations
Identify issues affecting the quality of clinical research programs and develop strategies to address them
Perform technical document reviews and support clinical development programs
Provide audit reports to management and lead quality improvement initiatives
Mentor peers and develop tools for tracking compliance management activities
What Is Required (Qualifications)
Bachelor's degree or equivalent in a relevant field
Minimum of 2+ years of Clinical Site Auditing experience
Must have GCP and auditing experience for clinical trials
Thorough knowledge of applicable GCP and regional regulations
Excellent oral and written communication skills with strong attention to detail
How To Stand Out (Preferred Qualifications)
Experience hosting client audits and/or regulatory inspections
Familiarity with auditing databases, eTMF, and Clinical Study Reports
Background in training and mentoring peers
Strong problem-solving skills and risk assessment abilities
Experience with study-specific audits or other GP audits
#ClinicalResearch #QualityAssurance #CareerOpportunity #ProfessionalDevelopment #Auditing
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