The Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Covance, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, as assigned and assumes line management responsibilities, as assigned. Acts in the project role of a Local Project Coordinator or Lead CRA as assigned.
Minimum Required: • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) • In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered • Thorough knowledge of regulatory requirements • Thorough understanding of the drug development process • Fluent in local office language and in English, both written and verbal
FOR GLOBAL REWARDS USE ONLY: Template Revised – October 2018 Page 5 of 5
• Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Preferred: • Thorough knowledge of company SOPs regarding site monitoring
Minimum Required: • Three-Four (3-4) years of Clinical Monitoring experience • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Advanced site monitoring skills • Advanced study site management skills • Advanced registry administration skills • Ability to work with minimal supervision • Good planning and organization skills • Good computer skills with good working knowledge of a range of computer packages • Advanced verbal and written communication skills • Ability to train and supervise junior staff • Ability to resolve project-related problems and prioritizes workload for self and team • Ability to work within a project team • Works efficiently and effectively in a matrix environment • Valid Driver's License
Preferred: • One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred • Local project coordination and/or project management experience
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed