Clinical Research Associate - Diagnostics

Clinical Research Associate - Diagnostics

Walker Cole International has partnered with a rapidly growing Diagnostics Company to hire Clinical Research Associates to join their Clinical Affairs Team in Boston, MA.

This is a full time hybrid position in Boston, open to CRA I’s through to Senior CRA’s. 

As the Clinical Research Associate you will be responsible for:

• Act as the main point of contact internally and externally for study sites
• Support the Clinical Affairs Team in all aspects of study/site start up
• Monitoring of remote clinical trials (at home self diagnostic testing)
• Continuously evaluate study performance
• Ensure adverse events, device complaints and protocol deviations are reported in an efficient manner adhering to protocol
• Provide efficient and timely monitoring reports to Clinical Affairs Team

Required experience for the Clinical Research Associate:

• Life Science Degree or Nursing Qualifications
• Minimum 1 years experience as a CRA independently monitoring
• Minimum 1 years in Medical Devices (commercial clinical trials)
• Experience in self-diagnostics is sought after
• Strong understanding of ICH GCP and Medical Device regulatory guidelines
• Valid Driving Licence

GCP | Clinical Research Associate | CRA | Medical Device | Diagnostics | FDA | Boston | Clinical Research | Clinical Trials | Clinical Operations