Clinical Research Auditor I

NMDP

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.

Posted 6/18/2026full-timeRemote • Minnesota • 🇺🇸 United StatesJuniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

data verificationregulatory reviewaudit analysisdata reporting complianceclinical trial managementelectronic data captureproblem solvingdata analysisreport authoringtrend synthesis

Soft Skills

independent judgmentrelationship buildingmentoringcommunicationcollaborationadaptabilityorganizational skillsprofessional guidancecontinuous improvementcreative problem solving

Tools & Technologies

clinical trial management systemselectronic data capture systems

Industry Keywords

NMDPCIBMTRGCDMPICH GCPFDA guidelinesclinical researchprotocol managementaudit findingsdata reportingtransplant center

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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