Job Description

Senior Clinical Research Associate (1 of 2) at J&J Family of Companies in Boise, Idaho, United States Job Description Senior Clinical Research Associate (1 of 2) - 2306143724W Description Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development. Patients First Innovation Winning Culture Heart Recovery Reporting to the Manager, Clinical Research Associates, the person in this role is responsible for the management of day-to- day aspects of investigational site activities on assigned clinical trials. The Senior Clinical Research Associate should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team. This person will be fully engaged and busy from the first day and we guarantee there will never be a dull moment. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications. Key Responsibilities: + Study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities + Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution. + Provide coaching and training to junior employees + Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases + Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve efficiencies within and across related functional areas + Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OU To view full details and how to apply, please login or create a Job Seeker account

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