Clinical Research Associate
December 1, 2022
remote (United States)
Job Type
Work Setting
Remote / Home-based, In-office


As a Clinical Research Associate, you will play a vital role in developing clinical evidence to support software such as medical device (SaMD) artificial intelligence (AI) products used in diagnostic medical imaging. Our focus is conducting studies and delivery of clinical evaluation (or another regulatory submission) activities and documentation by all applicable standards and regulations to produce quality clinical evidence supporting the regulatory and marketing strategy for products.
You will manage the end-to-end conduct of clinical and non-clinical performance studies evaluating SaMD AI products within the functional role of Study Manager for assigned studies. This is an excellent opportunity to learn to conduct clinical and non-clinical performance studies evaluating SaMD within the growing field of artificial intelligence.
Your accountabilities will be spread across study management and clinical evaluation activities (planning, reporting, literature reviews, and post-market clinical follow-up). You will manage the development of the study, clinical evaluation, and performance evaluation documentation (with cross-functional input) to support regulatory submissions.
What You'll Do
      • Manage the planning and timely execution of assigned studies;
      • Monitor, appropriately communicate, and manage the risk of assigned studies;
      • Develop key study documents (e.g., study protocols, ethics submissions, study plans, and study reports) with cross-functional input;
      • Assist with SOP development and maintenance as required;
      • Provide a cross-functional review of the clinical evaluation or other regulatory documentation such as clinical evaluation plans and reports, post-market follow-up plans and reports and literature review protocols, performance evaluation summaries, and clinical evaluation reports; and
      • Conduct or assist with literature reviews, manuscript submissions, and conference abstracts.

What Will Help You Succeed

    • Experience working within the medical device industry;
    • Experience working within the field of clinical research;
    • Bachelor’s degree in a relevant field (e.g., nursing, life sciences, or medical science); and

Strong understanding of ICH/GCP, ISO14155 2020, 2017/745 (EU MDR), 21 CFR

Nice to have (but not essential):

    • Experience with medical device regulatory submissions, especially for US FDA;
    • Experience working in research involving artificial intelligence, SaMD, and medical imaging;
    • Experience with medical and technical writing, including state-of-the-art and literature summaries;
    • Experience performing statistical analysis and programming expertise; and
    • Ph.D. and post-graduate qualification in a relevant area of medical science.
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