Clinical Research Auditor I
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Job Description
Clinical Research Auditor ensuring compliance with NMDP/CIBMTR Research Database Protocol and conducting audits at transplant centers. Analyzing findings and promoting data quality and continuous improvement.
Responsibilities:
- ensuring compliance with the NMDP/CIBMTR Research Database Protocol by independently conducting audits at Transplant and Cellular Therapy Centers.
- Requires working autonomously with center staff, interpreting complex reporting guidelines, making real-time decisions during audits, and exercising professional judgment to assess data reporting compliance without direct supervision.
- Leads site audits with a focus on data verification and regulatory review, utilizing independent judgment to identify, prioritize, and directly resolve data reporting issues in partnership with transplant center staff.
- Builds strong relationships with transplant center staff by leveraging mentoring and professional guidance, while effectively managing complex challenges through independent problem-solving and a commitment to continuous improvement.
- Analyzes patterns and root causes in audit findings, synthesizing trends into actionable insights and authoring follow-up reports that drive corrective and preventative strategies to support transplant center staff.
- Cultivates clear, constructive communication with site teams, providing technically sound guidance and confidently facilitating discussions that encourage collaboration and quality of the date being reported to CIBMTR.
- Assists in the development and testing of electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other applications as required.
- Other duties as assigned, often involving special projects that require the individual to plan, organize, and execute tasks with minimal supervision. These projects may necessitate creative problem solving, cross-functional collaboration, and the ability to adapt quickly to changing priorities.
Requirements:
- Bachelor’s degree in healthcare/science related field. However, upon evaluation, equivalent related experience and/or education may be substituted for the degree requirement.
- Minimum one year experience monitoring clinical research studies and/or protocol management according to GCDMP/ICH GCP/FDA guidelines or verifying clinical data from medical records.
- On evaluation, one year of previous experience in a Senior Clinical Data Analyst, Clinical Research Coordinator III, or equivalent position within the CIBMTR/NMDP may be substituted for the experience requirement.
Benefits:
- medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits
- Retirement
- paid time off/holidays
- leave and incentive plans
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