This position performs clinical trial monitoring visits to assess compliance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. Also performs data validation auditing by comparing source documents to NMDP registry data, analyzing the results and completing comprehensive summary reports. The position may also assist with centralized review of data, identifying data trends, and creating reports to support CIBMTR strategic initiatives.
Clinical research study processes, study design and/or protocol management.
Clinical trial monitoring procedures and clinical data reporting processes.
ICH GCP guidance and FDA regulations.
Good Clinical Data Management Practices (GCDMP).
Medical terminology and anatomy/physiology.
Microsoft Suite of software products.
Intermediate project management, training, and conflict resolution skills.
Perform tasks requiring excellent attention to detail.
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).
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 of two years’ experience (preferred) monitoring clinical research studies and/or protocol management according to ICH GCP/FDA guidelines or verifying clinical data from medical records.
On evaluation, one to two years previous experience as a CRA I 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)
Functional knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
ACRP or SOCRA certification.
Internal Number: 1900003R
About Be The Match
Be The Match® is the trusted leader in the field of cellular therapy. We never lose sight of our purpose—delivering cures for blood cancers. From the moment a patient is diagnosed, we are there every step of the way; helping their doctor find a donor, delivering life-saving cells to the patient’s bedside, and supporting patients through recovery and survivorship.
With over 30 years of experience, we are the trusted leader in advancing the science of transplant, conducting ground-breaking research and providing vital services for patient families when they need them most.
As the world’s largest registry and hub of a global network, our partners count on us to develop innovative solutions to improve transplant and fuel collaborative relationships essential to saving lives.