We are seeking an experienced Lead Clinical Auditor with a strong background in FDA regulatory compliance and clinical quality assurance to lead and manage clinical auditing processes for our organization. This role requires comprehensive knowledge of FDA regulations, GCP (Good Clinical Practice), and other regulatory requirements related to clinical trials. The successful candidate will be responsible for overseeing clinical audit programs, ensuring compliance across clinical operations, and guiding cross-functional teams to achieve high standards in clinical quality and regulatory adherence.
Key Responsibilities:
- Lead Clinical Audits: Plan, execute, and oversee clinical trial audits to assess compliance with FDA regulations, GCP standards, and internal protocols.
- Regulatory Compliance: Ensure adherence to all FDA guidelines and requirements for clinical trials, with a focus on GCP compliance and industry best practices.
- Risk Management: Identify potential areas of risk and non-compliance in clinical trial conduct and implement corrective actions to mitigate them.
- Audit Strategy Development: Develop and execute clinical audit plans, including risk-based audits, investigator site audits, internal process audits, vendor audits, and trial master file (TMF) audits.
- Continuous Improvement: Provide insights and recommendations to enhance clinical trial processes, ensuring alignment with FDA regulations and company policies.
- Training & Mentorship: Train and mentor clinical research teams on compliance, audit readiness, and best practices for conducting clinical studies.
- Documentation & Reporting: Prepare detailed audit reports, summarize findings, and communicate non-compliance issues with actionable recommendations for corrective actions.
- Cross-functional Collaboration: Work closely with clinical operations, quality assurance, regulatory affairs, and other teams to address audit findings and improve quality systems.
- Regulatory Inspection Readiness: Lead or support efforts to prepare for regulatory inspections, including FDA inspections, by ensuring documentation and processes are audit-ready.
Qualifications:
- Education: Bachelor's degree in Life Sciences, Clinical Research, Nursing, or related field; advanced degree preferred.
- Experience: Minimum 5+ years of clinical audit experience, with at least 2 years in a lead or senior role. Direct experience with FDA inspections and regulatory requirements is required.
- Certifications: RAC, CCRA, or other relevant certification is preferred.
- Knowledge: In-depth knowledge of FDA regulations, GCP, ICH guidelines, and clinical trial processes.
- Skills:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Ability to handle multiple audits/projects concurrently.
- Proficiency in audit tools and documentation systems.
- Detail-oriented with a commitment to quality and accuracy.
Contract Details:
- 12 Months
- H1B Sponsorship Unavailable
We are seeking an experienced Lead Clinical Auditor with a strong background in FDA regulatory compliance and clinical quality assurance to lead and manage clinical auditing processes for our organization. This role requires comprehensive knowledge of FDA regulations, GCP (Good Clinical Practice), and other regulatory requirements related to clinical trials. The successful candidate will be responsible for overseeing clinical audit programs, ensuring compliance across clinical operations, and guiding cross-functional teams to achieve high standards in clinical quality and regulatory adherence.
Key Responsibilities:
- Lead Clinical Audits: Plan, execute, and oversee clinical trial audits to assess compliance with FDA regulations, GCP standards, and internal protocols.
- Regulatory Compliance: Ensure adherence to all FDA guidelines and requirements for clinical trials, with a focus on GCP compliance and industry best practices.
- Risk Management: Identify potential areas of risk and non-compliance in clinical trial conduct and implement corrective actions to mitigate them.
- Audit Strategy Development: Develop and execute clinical audit plans, including risk-based audits, investigator site audits, internal process audits, vendor audits, and trial master file (TMF) audits.
- Continuous Improvement: Provide insights and recommendations to enhance clinical trial processes, ensuring alignment with FDA regulations and company policies.
- Training & Mentorship: Train and mentor clinical research teams on compliance, audit readiness, and best practices for conducting clinical studies.
- Documentation & Reporting: Prepare detailed audit reports, summarize findings, and communicate non-compliance issues with actionable recommendations for corrective actions.
- Cross-functional Collaboration: Work closely with clinical operations, quality assurance, regulatory affairs, and other teams to address audit findings and improve quality systems.
- Regulatory Inspection Readiness: Lead or support efforts to prepare for regulatory inspections, including FDA inspections, by ensuring documentation and processes are audit-ready.
Qualifications:
- Education: Bachelor's degree in Life Sciences, Clinical Research, Nursing, or related field; advanced degree preferred.
- Experience: Minimum 5+ years of clinical audit experience, with at least 2 years in a lead or senior role. Direct experience with FDA inspections and regulatory requirements is required.
- Certifications: RAC, CCRA, or other relevant certification is preferred.
- Knowledge: In-depth knowledge of FDA regulations, GCP, ICH guidelines, and clinical trial processes.
- Skills:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Ability to handle multiple audits/projects concurrently.
- Proficiency in audit tools and documentation systems.
- Detail-oriented with a commitment to quality and accuracy.
Contract Details:
- 12 Months
- H1B Sponsorship Unavailable