Cardiovascular Associates of America - CVAUSA

Compensation

Full Description

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: