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Job #02635

About our client Our client is a leading medical device company with over 500 employees. The company is focused on expanding its global distribution, fueling innovation and new products to broaden the company's product portfolio to become the world's cardiology device care leader. Position Location Clinical Research Associate Northeast, USA Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Monitor adverse experiences and other functions required for managing clinical trial conduct 2) Conduct periodic monitoring activities with the investigative sites, including the reviewing of Case Report Forms (CRFs), performing source document verification 3) Ensure compliance with Good Clinical Practice (GCP) guidelines and FDA regulations and monitoring device accountability 4) Review CRFs and perform data clarification functions 5) Conduct study closeout activities 6) Prepare, modify and distribute study materials such as CRFs, study reference manuals and monitor the guidelines/manuals 7) Participate in investigator meetings 8) Communicate with the Clinical Team members, including participation in team meetings and updates 9) Establish budget, contract and IRB approval with sites and investigators 10) Assist with the preparation of FDA submissions 11) Establish in-house SOPs as needed 12) Assist in designing, planning and conducting high quality clinical research trial and/or data registries 13) Ensure safety and effectiveness of the client’s products Requirements 1) Minimum 2 years of experience 2) 2 – 8 years of experience 3) Experience in cardiology and PMA (510k) preferred 4) Experience in medical device or drug clinical trial preferred 5) Willingness to travel – up to 20%(overnight)