Job Overview The Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Fortrea, 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.
Must be based in Rome area. Summary of Responsibilities Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs)

or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure audit readiness at the site level. Travel, including air travel, may be required and is an essential function of the job. Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned. Conduct, report, and follow-up on Quality Control (QC) visits when requested.
Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned. Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Assist with training, mentoring and development of new employees, e.g., co-monitoring. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a l

Senior clinical research associate ii

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Agente di Commercio Monomandatario - Settore Alime

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