Clinical Research Associate

Position Overview

Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

Key Responsibilities

• Site Management & Monitoring:
  • Conducts in-house monitoring and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Participates in assessing study risks.
  • Communicates on behalf of the study manager with investigators and site staff.
  • Prepares study performance reports and provides input into study budgets.
• Study Implementation:
  • Assists in the preparation and independent execution of study training presentations for investigators and site staff.
  • Coordinates study supply ordering, shipping, investigational product release, labeling, and accountability at study sites.
  • Facilitates site readiness, implements site monitoring plans, and supports assay transfer and assay qualification activities.
  • Manages study records including site and trial master files and compiles documents for clinical study reports.
  • Supports data management activities including user acceptance testing, data entry, and verification as needed.
• Departmental Roles:
  • Works within project teams to facilitate the conduct of standard study designs.
  • Participates in clinical affairs meetings and supports departmental functions.
  • Completes all internal training programs in a timely manner and pursues ongoing professional development.
  • Adopts clinical practices that promote Quality First Time.

Required Qualifications

• Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.
• 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience.
• Excellent computer skills using Word, Excel, Access, and PowerPoint.
• Superior writing and verbal communication skills.
• Well organized, detail oriented, with impeccable record keeping and excellent time management skills.
• Ability to work effectively in a team as well as independently on assigned tasks.
• Ability to complete intermittent overnight travel up to 30%.

Preferred Qualifications

• Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR).
• A background in biomedical/healthcare services with laboratory experience.