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Clinical Research Associate II
Ref No.: 18-04059
Location: Tucson, Arizona
This is an excellent opportunity to join the global leader in the medical diagnostic industry by exploring this great opportunity for a professional wanting to grow in their career to work with a Fortune 100 company.

POSITION SUMMARY:
Responsible for the conduct and management of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by the Medical Systems. Works independently to complete CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

ESSENTIAL FUNCTIONS:
  • Conducts most aspects of site management and independently monitors study activities according to  Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Conducts study risk assessments and applies the principles of risk-based monitoring.
  • Communicates with investigators and site staff across multiple studies.
  •  Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Assay transfer and assay qualification activities.
  •  Study records including site and trial master files.
  •  Site qualification, site initiation, routine monitoring and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed.
  • Departmental Roles: Works across multiple project teams, indications, and differing study designs.
  • Participates in clinical affairs meetings, and may represent the department on cross functional project teams, interfacing with representatives from other functional groups including: quality, product development, manufacturing, marketing, customer service and regulatory affairs.
  • Completes all internal training programs in a timely manner, and acquires professional, product and market expertise via independent reading, networking and training.
  • Proactively supports improved clinical processes within the Ventana Quality System to ensure Quality First Time.
MINIMUM QUALIFICATIONS:
  • Bachelor of Science, RN or BSN preferred; OR equivalent combination of education and clinical experience.
  • Experience: 4+ years clinical research experience.
  • 2+ years of in-house CRA experience or IVD study experience preferred.
  • Extensive background in biomedical/healthcare services with laboratory experience preferred.
  • Previous experience with investigational product management, case report form (CRF) development, protocol or report writing, and data management
  •  Knowledge of current Good Clinical Practices (cGCP) and Regulations.
  • Knowledge of typical experimental designs to characterize the performance of an IVD or Medical Device.
  • Proficient with standard software applications (word processing, spreadsheets, presentations) as well as Microsoft Visio and Microsoft Project.
**Ability to complete intermittent overnight travel up to 50%.