Clinical Research Associate II

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

• Serves as liaison between Myriad clinical development team and research site staff with respect to tactical elements of study completion
• 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 specialist
• 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
• Communicates site enrollment and study metrics through maintenance of tracking tools
• Maintains trial master files for assigned clinical research projects
• Maintains professional expertise through familiarity with up-to-date medical and clinical operations knowledge and familiarity with Myriad's product pipeline.
• Works independently with minimal instruction and routine supervision by senior level CRA or functional manager
• Field site travel up to 30%

• Bachelor Degree: RN/BS/BA; scientific discipline preferred
• Minimum of 2 years of Clinical Research Associate experience in diagnostics, pharmaceutical, medical device, or CRO setting
• Knowledge of medical terminology, clinical monitoring procedures (SOPs), 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.

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PI100211947