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! Apply tot his job Apply tot his job Apply To this Job