Clinical Research Auditor I

🔥 14 hours ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟢 Junior

🔎 Auditor

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NMDP

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1987

🤝 Non-profit

🤲 Charity

🔬 Science

Non-profit • Charity • Science

NMDP is a nonprofit organization (formerly Be The Match) that operates the national blood stem cell donor registry and coordinates cell therapy to treat blood cancers and other blood disorders. It recruits and registers donors, matches donors to patients, facilitates transplants, provides patient support and financial assistance, conducts and funds clinical research and trials, and leads advocacy and fundraising to expand access to life‑saving cell therapies.

📋 Description

• 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