Independent Contractor – Clinical Trials Quality & Compliance Manager

October 16

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Cardiovascular Associates of America - CVAUSA

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Headquartered in Orlando, Cardiovascular Associates of America aims to bring the best cardiovascular physicians in one network with the common mission of saving lives, reducing costs, and improving patient care through clinical innovation. Through CVAUSA’s physician-centered practice management model, physicians drive clinical care and their practice culture, while benefiting from the business expertise and shared resources available through CVAUSA.

51 - 200 employees

Founded 2021

📋 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.