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Clinical Research Associate II
Posted on 3/16/2023
Experience Level
Desired Skills
Google Cloud Platform
  • Minimum Bachelor's Degree, preferably in a life science or health science discipline
  • Minimum 3 years of related experience, preferably including clinical research and clinical operations experience
  • Experience working in IVD clinical studies highly preferred
  • Computer software skills (e.g., MS Word, Excel, PowerPoint and Google products experience)
  • Strong attention to detail, self-motivation, and good organizational skills
  • Ability to multi-task and ability to work both as part of a team and independently
  • Proactive approach, with high sense of urgency and results orientation
  • Progressive thinker, innovative and open-minded
  • High levels of integrity, intellectual honesty and maturity
  • Knowledge of FDA requirements for clinical validation and CLIA waiver
  • Knowledge of ICH GCP
  • Create monitoring plans, case report forms, informed consent forms, and other required documents for clinical studies
  • Develop and write clinical protocols with guidance
  • Serves as a lead CRA conducting site qualification, selection, initiation, monitoring, and closeout visits in compliance with GCP and approved protocols; write site visit reports timely
  • Approves data management plan
  • Establish and update various databases for clinical study monitoring and tracking
  • Collaborate with Data Manager and/or Clinical Affairs management to define data management plan and design CRFs
  • Negotiate budgets and prepare contract agreements with study sites, vendors and CROs, as applicable
  • Provide training to study sites; review study site documents (e.g., regulatory documents, investigational product accountability logs and source documents)
  • Maintain effective, professional, timely, and consistent communications with clinical site PIs, coordinators and other site personnel
  • Identify and report issues, problems or any protocol deviations that could affect the studyresults and completion timeline; propose solutions to the Director
  • Create, update, and maintain study TMFs for completeness, compliance and accuracy
  • Ensure timely completion of the clinical deliverables according to project timelines
  • Review and submit invoices received from sites and maintains accurate accruals
  • Ensure studies are conducted in accordance with GCP, US FDA regulations and OUS IVD regulations (as applicable)
  • Prepare clinical study reports and relevant sections of regulatory submissions with guidance
  • Perform specialized functions within the clinical affair departments, such as management of clinical research assistants, lead TMF audit, mentor team member, provide training, and/or write SOPs as appropriate
  • Actively participate in optimization of department practices to ensure compliance and drive efficiency
  • Perform other duties and projects as assigned
Visby Medical

501-1,000 employees