Clinical Research Auditor I

POSITION SUMMARY:

This role ensures compliance with the NMDP/CIBMTR Research Database Protocol by conducting audits at Transplant and Cellular Therapy Centers. It demands strong professional judgment, real-time decision-making, and the ability to interpret and apply complex data reporting guidelines. The position involves performing data validation audits that involve comparing source documents to NMDP registry data, identifying discrepancies, and ensuring accurate reporting. The auditor analyzes findings to detect patterns, generate actionable insights, and develop clear, concise follow-up reports that drive corrective actions. Additionally, the role requires building and maintaining collaborative relationships with center staff, effectively communicating technical guidance, and promoting a shared commitment to data quality and continuous improvement.

ACCOUNTABILITIES:

• This role is responsible for 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.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Clinical research study processes, study design and/or protocol management.
  • Medical terminology and anatomy/physiology.
  • Microsoft Suite of software products.
  • Training and conflict resolution skills.
  Ability to:
  • Execute responsibilities with a high level of attention to detail, ensuring accuracy and consistency across complex tasks.
  • Communicate clearly and professionally with staff and site personnel, both verbally and in writing, often interpreting complex technical information and adapting messaging to suit varied audiences and situations.
  • Independently manage multiple, competing deadlines and priorities, exercising strategic judgment to balance workload, allocate resources effectively, and consistently deliver high-quality results with minimal supervision.
  • Operate effectively in a remote work environment, demonstrating strong self-motivation, time management, and accountability to maintain productivity and meet organizational goals.
  • Travel approximately 35-50%, both domestic and international, depending on audit schedule. Travel at times may increase up to 70% as required. Must operate independently while on travel, representing NMDP professionally and upholding NMDP Standards through sound judgment and self-directed action in diverse and sometimes high-pressure settings.
  Education and/or Experience:
  • 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.
  PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
  • Knowledge of blood and marrow transplant clinical research and medical field.
  • ACRP or SOCRA certification.

Originally posted on Himalayas