Clinical Research Associate

Under the direction of the Program Manager and Clinical Trial Manager, the Clinical Research Associate I contributes to the tactical implementation and conduct of clinical research studies. The CRA I ensures the quality of each research study through on-site and centralized monitoring of protocol and regulatory compliance. The CRA I represents Myriad at the research site level and maintains collaborative relationships with investigator sites and the internal clinical development team.

*** This position can be based in Salt Lake city, Utah or Mason, Ohio***

Responsibilities

• Serves as liaison between Myriad clinical development team and research site staff with respect to tactical elements of study completion
• Assesses site qualification potential (reviews study requirements and identifies sites through feasibility and qualification visits)
• Completes study start-up activities:
  • Assists with creation of study tools and training materials
  • Directs site staff through start-up activities in collaboration with regulatory associate
  • Conducts on-site initiation, interim monitoring and close-out visits per Myriad SOP to ensure data integrity and good clinical practice; writes visit reports
    Conducts centralized monitoring tasks (remote data review for identification of queries, data trends, deviations, issue escalation, etc.)
  • Verifies and fulfills site supply requests for product/study materials
  • Tracks and escalates any safety events
  • Drafts CAPA/intervention plans
  • Tracks enrollment and manages accrual issues
  • Maintains trial master files for clinical research projects
  • Maintains professional expertise through familiarity with up-to-date medical and clinical operations knowledge
  • Works with oversight from more senior level CRAs and Program Managers
    Field site travel up to 50%

Qualifications

• Bachelor Degree: RN/BS/BA; scientific discipline preferred
• Minimum of 1 year of Clinical Research experience in diagnostics, pharmaceutical, medical device, academic or CRO setting
• Knowledge of medical terminology, clinical monitoring procedures, and ICH/GCP guidelines
• Ability for attention to detail and accuracy in work
• Excellent written and oral communication skills
• Excellent organizational and time management skills
• Strong computer skills including Microsoft Office

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.