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Sr. CRA, FSP - Cardiac & Medical Device - Canada

lifelancer·US·United States·senior
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Job Title: Sr. CRA, FSP - Cardiac & Medical Device - Canada Job Location: Remote Canada Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Fortrea's FSP team is seeking experienced Sr. CRAs based in Canada with complex cardiac experience within the past 5 years , preferably in electrophysiology and / or devices . Must have 3+ years of monitoring experience. This role will include some nationwide travel during start up. Job Overview: The Senior CRA II is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned. Summary of Responsibilities: The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties. Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. 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 implausi