Clinical Research Associate

13 hours ago


Boston, United States ALKU Full time

Clinical Research Associate (IVD)


Background: The client is a mid-sized medical device diagnostic company that focuses on laboratory equipment. They are in need of a Clinical Research Associate that will be in charge of site management for multiple sites focusing on IVD equipment. They will be tasked with overseeing this site from study start up to close out and need to be familiar with all phases. This role will be heavily focused on on-site and remote monitoring. They are looking for a CRA to be able to travel about once every six weeks to their assigned sites in Nebraska, Indiana, Missouri, & Ohio. Experience as a CRA for an IVD sponsor is going to be a necessity for this role.


  • The candidate should have the following: Experience with In Vitro Diagnostics
  • Utilize your experience with laboratory instrumentation to evaluate and monitor the functionality of diagnostic devices during clinical trials. Assist in troubleshooting and ensuring the equipment is calibrated and maintained properly.
  • Strong GCP, Compliance, study documentation, IRB, TMF expertise
  • Clinical Site management experience
  • Experience directly interfacing with clinical sites, managing site metrics, ability to lead site meetings/visits, etc.
  • Strong Communication and Organization Skills
  • Testing Data monitoring
  • Reviewing clinical testing data from instruments (IVD) against applicable clinical protocols



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