Senior Clinical Research Associate

2 weeks ago


Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full time
Position Overview: Senior Clinical Research Associate at BrioHealth Solutions

BrioHealth Solutions is on the lookout for skilled Clinical Research Associates (CRAs) to enhance our team and support the development of our cutting-edge LVAS device. As a Senior CRA, you will be instrumental in overseeing clinical trial data and ensuring the effective execution of our research initiatives.

Key Responsibilities:
  • Establish and manage study documentation, overseeing eTMF and supporting CTMS operations.
  • Coordinate clinical study sites, ensuring the provision of trial materials and delivering training to site personnel.
  • Oversee study management tasks including eTMF documentation, preparation of trial reports, and monitoring of adverse events.
  • Facilitate investigator meetings, conduct pre-study assessments, and nurture relationships with clinical sites.
  • Handle submissions to IRBs/ECs and Regulatory Authorities, manage device accountability, and oversee trial supplies.
  • Independently generate reports, conduct User Acceptance Testing, and revise SOPs as necessary.
Required Qualifications:
  • Bachelor's degree or higher in a relevant scientific discipline.
  • Demonstrated expertise in clinical trial operations and relevant regulatory frameworks.
  • Familiarity with GCP, medical terminology, and statistical methodologies.
  • A minimum of 3 years of experience in clinical trials for medical devices.
  • Readiness to travel frequently as required.

For Senior CRA applicants:

  • At least 8 years of clinical research experience, particularly in medical device trials.
  • Comprehensive knowledge of FDA regulations, protocol formulation, and experience leading CRA teams.

About BrioHealth Solutions Inc:

BrioHealth Solutions is comprised of dedicated Med-Tech professionals committed to developing patient-focused solutions. Our BrioVAD LVAS technology is designed to offer chronic mechanical circulatory support to patients with heart failure globally. Join us in our endeavor to enhance patient outcomes and broaden access to essential therapies.



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