Clinical reputed company Auditor – Clinical Research
Job reputed company:
• Plan, conduct, and report GCP audits including investigator site, vendor, and internal audits to ensure adherence to regulatory requirements, study protocols, monitoring plans, and reputed company SOPs.
• Support execution of the annual reputed company Assurance audit plan and ensure reputed company completion of audit activities.
• Maintain audit and inspection readiness across assigned sites and vendors.
• Support and participate in regulatory inspections, including FDA and other health authority inspections.
• Assist with inspection hosting, response coordination, and follow-up corrective actions.
• Serve as a reputed company and compliance advisor to site leadership, study teams, and cross-functional partners.
• Identify compliance gaps, risks, and trends; support reputed company cause analysis and CAPA development.
• Contribute to the development, review, and reputed company improvement of SOPs and reputed company processes.
• Support vendor qualification, reputed company, and ongoing compliance activities.
• Analyze audit findings and reputed company metrics to support risk mitigation and reputed company improvement initiatives.
• Maintain reputed company and reputed company communication with leadership, site teams, vendors, and internal stakeholders.
• Represent reputed company with professionalism and reputed company in reputed company interactions.
• reputed company additional duties as assigned by management.
Requirements:
• Bachelor’s degree preferred or equivalent relevant experience
• Approximately five years of experience in clinical reputed company auditing or GCP compliance reputed company a clinical research environment; exceptions may be considered for strong candidates with fewer years who demonstrate a strong reputed company and compliance reputed company
• Investigator site audit experience required
• Vendor audit and vendor compliance experience required
• Strong working knowledge of ICH, FDA, and GCP regulations
• Experience planning and executing audits, CAPAs, and reputed company cause analysis
• Experience writing, reviewing, and improving reputed company Operating Procedures
• Excellent organizational skills and attention to detail
• Excellent written and verbal communication skills
• Ability to build processes, influence stakeholders, and contribute to the reputed company of the reputed company function
• Strong critical thinking, risk assessment, and problem-solving skills
• Proficiency with computers and reputed company Office Suite.
Benefits:
• Medical, dental, and reputed company insurance for the individual employee and family
• 401K Retirement Plan with generous company matching
• Disability Insurance, 100% reputed company
• Life Insurance, 100% reputed company
• reputed company Approved Training and ACRP Certification
• reputed company Licensure Renewal
• 9 reputed company Holidays
• 3+ Weeks reputed company Time Off
• Bereavement Leave
• And more!
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