Note: The job is a remote job and is open to candidates in USA. NMDP is an organization supporting transplant and cellular therapy research and data quality. The Clinical Research Auditor I conducts independent audits of transplant and cellular therapy centers, validates clinical data, identifies reporting issues, and prepares follow-up reports. The role also collaborates with center staff and supports the development and testing of electronic data capture and clinical trial management systems.
Responsibilities
- 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
Skills
- 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
- Knowledge of blood and marrow transplant clinical research and medical field
- ACRP or SOCRA certification
Benefits
- Regular, full-time employees are offered medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits.
- Retirement is offered to eligible employees.
- Paid time off and holidays are offered to eligible employees.
- Leave is offered to eligible employees.
- Incentive plans are offered to eligible employees.
- Remote work arrangement
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