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Clinical Research Associate

Visby Medical

Visby Medical

San Jose, CA, USA
Posted on Thursday, May 23, 2024

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About the role

The Clinical Research Associate (CRA) will assist the clinical team with the conduct of qualification, initiation, monitoring and close out visits at research sites. CRA should be able to run studies in compliance with approved protocols to ensure protocol adherence, communicate with study sites to ensure timely enrollment of patients and promptly respond to study related queries. Other critical duties will include source data verification on the EDC software, keeping the TMF updated, and writing visit reports.

How you'll make an impact

  • Assist the clinical team with conducting qualification, initiation, monitoring, and closeout visits at research sites in compliance with approved protocols.
  • Establish and update various databases for clinical tracking.
  • Maintain effective, professional, timely, and consistent communication with medical site staff including coordinators, clinical research physicians and their staff.
  • Create, update, track, and maintain study-specific trial management files.
  • Support clinical research start-up activities (includes creation of study logs, work instructions, case report forms, and other study materials).
  • Ensure delivery according to project timelines.
  • 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 (e.g. verification and submission of clinical study related invoices to internal Finance/Accounting teams payments to investigators, travel planning, etc.).
  • Assist with preparing, copying, and printing regulatory submission documents.
  • Assist with coordinating and conducting testing in support of regulatory submissions.
  • Approximately 20-30% travel is required.
  • Other duties as assigned.

On your first day we'd like you to have

  • Bachelor’s Degree, preferably in a life science or health science discipline.
  • Minimum 1-2 years of experience working in the healthcare industry or in a research function which involved clinical research and clinical operations.
  • Start-up experience preferred.

It's great if you have

  • Strong computer software skills (Google Suite, MS Word, Excel, PowerPoint, and experience).
  • Strong communication and presentation skills.
  • Strong attention to detail, self-motivation, and good time management & organizational skills.
  • Ability to multi-task and ability to work both as part of a team and independently.
  • Proactive approach, with high sense of urgency and results orientation.
  • Progressive thinker, innovative and open-minded.
  • High levels of integrity, intellectual honesty and maturity.
  • Knowledge of FDA requirements for clinical validation and CLIA waiver.
  • Knowledge of FDA, ICH, and GCP requirements.

Salary Range:

  • $75,000 - $95,000 (salary range for candidates based in San Jose, CA)
  • Compensation for the role is based on geographical location. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.
  • Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.

More about our benefits

Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.

Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.

Additional information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.