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Clinical Research Associate for Virtual Studies

San Mateo, CA
Evidation Health is seeking a motivated candidate who is passionate about defining value within digital health as a member of an agile, entrepreneurial team. As a Clinical Research Associate for virtual studies, you will engage with an experienced cross-functional team to support the setup and execution of clinical utility digital health studies. You will be responsible for study product configuration, protocol compliance and data quality monitoring, and other study management activities for a range of studies across the portfolio. As a member of the Health Outcomes Research team, you will collaborate with the client success and product/engineering teams to ensure clinical studies meet or exceed high quality standards. This role is based in San Mateo, CA.
  • Conduct study setup activities including configuring proprietary study product according to protocol
  • Conduct study product testing prior to study launch
  • Develop and set up protocol compliance and data quality monitoring plans
  • Conduct protocol compliance and data quality monitoring on a daily basis
  • Validate and approve participant flow and data flow through the study
  • Collaborate with Study Support Specialist to address participant issues when necessary
  • Track and report on study metrics during recruitment, enrollment, and data collection
  • At times, assist in preparing and reviewing IRB submissions, informed consent forms, case report forms, and patient support materials
  • Participate in study setup and management process improvement activities within the department and cross functionally, including SOP development
  • Participate in proprietary study product development planning and feedback sessions
  • Minimal travel required; may occasionally conduct client and/or site visits
Desired Skills and Experience
  • Undergraduate university degree required
  • Research experience required, experience with clinical research preferred
  • Familiarity with HIPAA, human subjects research, and good clinical practices preferred
  • Strong project management, organizational, and interpersonal communication skills
  • Excellent attention to detail
  • Efficient multi-tasker able to juggle multiple projects simultaneously
  • Works well independently and with minimal direction at times
  • Versatile team player with affinity for collaborative environment
  • Proficient in Microsoft Word, Excel, and PowerPoint
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