San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.

We are developing a tenacious team with deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Clinical Research Assistant opportunity.

Summary

The Clinical Research Assistant is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team.

Essential Duties 

  • Provide general support to the Clinical Affairs and Regulatory Affairs Group by assisting with the execution and maintenance of clinical studying and preparation of regulatory documents.
  • Establish and update various databases for clinical tracking.
  • Create, update, track, and maintain study-specific trial management files.
  • Order, ship, and maintain clinical study supplies and in-house clinical inventory.
  • Ship and track investigational materials to study sites.
  • Prepare study binders for the clinical sites.
  • Coordinate technical support for field monitors.
  • Assist the Clinical team with administrative activities as required (payments to investigators, travel planning, photocopying, making labels, etc.).
  • Assist with the preparation copying, and printing of regulatory submission documents.
  • Assist with coordinating and conducting testing in support of regulatory submissions.
  • Assist in planning team meetings.
  • Maintain in-house Clinical Biorepository.
  • Other duties as assigned.

Education and/or Experience

  • Bachelor’s Degree, preferably in a life science or health science discipline.
  • Minimum 1-2 years of related experience, preferably including clinical research and clinical operations experience.
  • Experience working in healthcare industry or research function preferred.

Other Qualifications

  • Computer software skills (MS Word, Outlook, PowerPoint, and Access experience).
  • Strong attention to detail, self-motivation, and good organizational skills.
  • Ability to multi-task and ability to work both as part of a team and independently.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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