Job Description:
• Drive audit readiness. Ensure every site is prepared for sponsor, CRO, or regulatory inspections by building systems that make compliance second nature.
• Conduct oversight. Lead annual routine audits and for-cause audits, providing clear findings and guiding sites toward corrective action and continuous improvement.
• Lead regulatory processes . Oversee IRB submissions, regulatory document management, and adherence to ICH-GCP, FDA, and sponsor requirements.
• Design and deliver training . Develop and administer onboarding and ongoing training programs for investigators, coordinators, and site staff that reinforce compliance and protocol adherence.
• Establish startup processes . Build and standardize workflows for new sites to ensure efficient, compliant, and high-quality study activation.
• Embed quality systems . Develop and monitor processes for accurate data collection, entry, and protocol compliance, ensuring integrity across trials.
• Support and mentor. Serve as a trusted resource for research teams—providing training, guidance, and coaching to help sites succeed in compliance and quality.
Requirements:
• Proven (5+ years) experience in regulatory compliance and quality oversight for industry-sponsored clinical trials.
• Strong knowledge of ICH-GCP, FDA regulations, IRB processes, and clinical trial audit practices.
• Hands-on experience conducting site-level audits and inspections.
• Expertise in designing and administering training programs for research staff.
• Experience developing SOPs, startup processes, and compliance frameworks for new and existing sites.
• Excellent communication and leadership skills with the ability to influence and guide teams across multiple practices.
• A self-starter who thrives on building, refining, and scaling compliance processes in a complex, multi-site environment.
• 3+ years of experience conducting routine audits, for-cause audits, and inspection readiness assessments.
• Demonstrated success training and mentoring site teams to achieve protocol adherence and regulatory compliance.
• Experience establishing site startup processes and scaling training/quality programs across a network.
• Experience leading audit readiness initiatives and responding to sponsor/regulatory audits.
• Familiarity with Clinical Trial Management Systems (CTMS) and their regulatory/quality modules.
• Have helped at least 2 clinical trial sites with minimal/no research experience successfully start up clinical trial operations and participate in clinical trials.
Benefits:
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