Clinical Research Associate – Viz.ai

74% 1-Year Employee Growth Rate | 156% 2-Year Employee Growth Rate | LinkedIn | $0 Venture Funding

What Is Employee Growth Rate & Why Is It Important?

About Viz.ai

Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company’s Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with Threshold Ventures, CRV, and Google Ventures.

You will:

• Proactively work to ensure Viz clinical compliance by working closely with trial/study sites
  from study startup until study close.
• Assist with study site selection process (approach, nominate, qualify).
• Conduct site assessment and initiation visits, routine monitoring visits and study close-out
  visits.
• Provide periodic updates on site and/or study status, as requested by Viz Clinical Leadership
• Review study documents (e.g., templates) for accuracy and completeness.
• Ensure study payments are completed and tracked, on time, according to trial agreement.
• Maintain good communication with sites through telephone calls, emails, and
  correspondence.
• Ensure high quality data and conduct at sites and assist in preparation of monthly tracking
  reports.
• Read and understand complex clinical trial protocols, and develop tools, trackers, and source documentation, as needed.
• Train site research staff on therapeutic areas, protocol requirements, proper source
  documentation and case report form completion – including training tools and training
  materials.
• Ensure compliance with SOPs, local regulations, ICH and GCP guidelines.
• Support Clinical affairs leadership in key study execution tasks.
• Maintain study specific folders (Dropbox, Google drive, etc.) and study level Trial Master File
  (TMF).
• Assist in developing study-related materials such as training slides, document templates
  (Delegation of Authority Log, training logs, etc.), reports and newsletters.
• Review Site Activation Checklist to ensure all required elements and documents are
  included.
• As applicable, liaise with Customers/KOLs, Investigators, Customer Success, Research and
  Development, Regulatory and other internal personnel.
• Submit protocol, consent documents for ethics/IRB approval.

You will love this job if:

• You enjoy close collaboration across multiple teams.
• You are comfortable working with remote teams and are flexible with work schedules.
• You are keenly interested in clinical processes and the regulations that govern them.
• You are passionate about delivering quality service to customers, knowing that work in
  clinical research ultimately impacts patient safety.
• You are eager to learn and care about your contribution to life sciences.

Requirements:

• 1-3 years as a Clinical Research Associate (CRA) with medical device or related
  experience.
• Knowledge of medical device or biotechnology industry, terminology, and practices.
• Knowledge of FDA regulations and Good Clinical Practices (GCP) and their practical
  implementation.
• Knowledge of clinical trial execution process, e.g., site selection, budget & contract
  negotiation, monitoring.
• Experience of running clinical trials, working with investigators, site personnel, and internal
  stakeholders.
• Proficient computer skills including Google Suite (Docs, Sheets, Slides), Microsoft Office Suite
  (Word, Excel, PowerPoint) and relevant clinical applications (e.g., Electronic Data Capture)
• Available to travel as needed (up to 30%) and ability to manage travel schedules, such as
  flight schedules.

Preferred:

• CRA with Software as a Medical Device (SaMD), or related experience highly preferred.
• A general familiarity with neuro, cardiac or vascular technologies.
• Previous related experience in research within a clinical or corporate setting or relevant
  clinical experience in a clinical/hospital environment.
• Completed or in process of acquiring certification as a Research Professional by Society of
  Clinical Research Associates (SCRA) or Association of Clinical Research Professionals
  (ACRP).
• The ability to exchange straightforward information, ask questions, and check for
  understanding.
• Work habits include organization, coordination of many tasks, accuracy, and attention to
  detail
• Strong written and verbal communication and interpersonal skills.
• The ability to work independently when necessary.

What success looks like:

• You are determined to continuously improve your skills and work performance.
• You take responsibility of your tasks and proffer your support to the larger team as needed.
• You apply the Viz core values in your everyday conduct at work.
• After 90 days, you are taking incremental tasks to manage clinical compliance at study sites.

Viz offers competitive benefits, including medical, dental, vision, 401k, generous vacation, and other
great benefits to full-time employees.

Viz.ai is an Equal Opportunity Employer and considers applicants for employment without regard to
race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis
forbidden under federal, state, or local law. If you’re applying for a position in San Francisco, review
the San Francisco Fair Chance Ordinance guidelines applicable in your area.

Tagged as: >100% 2 Yr Employee Growth, 201-500 Employees, Hide US-Only Jobs