Clinical Research Associate II Job in Plymouth, Minnesota US
Clinical Research Associate II
Covidien is seeking a Clinical Research Associate II to work with the Clinical Research Manager to satisfy applicable regulatory standards and company requirements for worldwide Clinical Studies. This position bridges the responsibilities of the CRA-1 and the Clinical Research Specialist, and focuses on study management activities, oversight of CRO etc. PRINCIPLE ACCOUNTABILITIES - Assist with successful conduct of assigned studies consistent with the Clinical Strategy. This includes interfacing with representatives from key functional groups including Field Monitoring, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, RD, and European Clinical Groups. - Assist in preparation of study related material and training materials - Assist with training of investigators, center staff and ev3 staff - Work with Clinical Research Manager to develop plan to ensure device accountability for clinical sites - Assist Clinical Field Specialists and Clinical Research Manager in obtaining all necessary documents from clinical sites prior to site initiation and updating documents as determined by needs and length of trial - Review and verify adequacy of center activation documentation - Coordinate and conduct monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents - Review monitoring reports and identify discrepancies in reports and study files and ensures correction activities are completed - Review clinical data/information and oversee data correction - Assist Clinical Research Specialists in providing interim and final reports and presentations - Provide input to study budgets and project plans - Work with the Clinical Research Manager to oversee the organization of the Master File and Site files for Clinical Trials - Assist with second and third pass data entry as needed - Perform Site Qualification, Monitoring, and/or Close-out visits as requested - Perform audits of sponsor monitoring, sites files, CROs - Assist Clinical Research Manager by providing sections of Investigational Plan or protocol as needed - Assist Clinical Research Manager in writing sections of PMA Clinical Reports - Take initiative to oversee activities of Contract Research Organizations (CRO) - Assist in the preparation of materials for CEC and DSMB meetings - Assist in support of data validation and database closure as directed - Acquire professional, product and market expertise via independent reading, networking and training - Comply with applicable FDA and international regulatory laws/standards, the ev3 Code of Conduct, including company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) - Position may require up to 30% travel