Please apply online using a laptop or desktop computer. POSITION SUMMARY : This position performs data validation auditing by comparing source documents to NMDP registry data, analyzing the results, and completing comprehensive summary reports.
The position will assist with centralized review of data, identifying data trends, and creating reports to support CIBMTR strategic initiatives.
Also, may participate in clinical trial monitoring visits to assess compliance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.
This is a remote position (US), however candidates must be located within 60 minutes of a major US airport, as this role does require approximately 50% travel to conduct bi-monthly audits.
LI-Remote Check out our video Saving Lives : It's the Best Job Ever ACCOUNTABILITIES :
- This role ensures compliance with clinical trial protocols and regulations and / or manages and conducts the audit process at Transplant and Cellular Therapy Centers.
- Conducts audit or monitoring visits at sites to perform source data verification of critical data and study file (regulatory) review and addresses identified issues directly with site staff.
- Receives guidance and mentoring to manage complex issues.
- With oversight and guidance, analyzes trends in identified issues and write visit follow-up reports. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action.
- Communicates with sites to effectively resolve issues. Provides clear and technically accurate information, both orally and in writing.
- 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. 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 :
- Perform tasks requiring excellent attention to detail.
- Communicate clearly and effectively to staff and site personnel through oral and written formats.
- Manage multiple deadlines and priorities while ensuring quality and timeliness.
- Work effectively and efficiently in a remote environment.
- Travel up to 70% of time (domestic and international).
- Must exemplify our NMDP Standards. 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. DEI COMMITMENT : As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP.
We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.
BENEFITS : NMDP offers regular, full-time employees 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 are also offered to eligible employees. Please reference this link for more information : NMDP Benefit Information
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