Compliance Administrator
Omnidian
Independent Contractor – Clinical Trials Quality & Compliance Manager
Cardiovascular Associates of America - CVAUSA
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancequality oversightclinical trial audit practicessite-level auditstraining program designSOP developmentstartup processescompliance frameworksinspection readiness assessmentsdata collection and entry
Soft skills
communication skillsleadership skillsinfluencing skillsmentoringguidanceself-starterproblem-solvingteam collaborationcoachingcontinuous improvement
