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Job #02913

About our client Our client is a leading medical device company based in the Northeast. They specialize in developing technologies for the treatment of cardiovascular diseases, such as coronary stents and state-of-the-art hernia repair. The company has offices in Australia and The Netherlands and boasts a demand of over 2 million sterile medical products to over 60 countries every year. With emphasis placed on personal development of employees, this is a great opportunity for the right candidate! Position Location Clinical Research Associate – East Hudson, New Hampshire Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct site visits and monitor clinical studies 2) Coordinate clinical activities to ensure compliance with protocol and overall clinical objectives 3) Assist with protocol development and project oversight of single and multi-center clinical studies 4) Prepare protocols, investigator’s brochures, CRFs, ICFs and other specialized documents 5) Propose and negotiate budgets for clinical investigations 6) Analyze and evaluate data from clinical sites to ensure completeness as well as accuracy 7) Prepare clinical reports (as needed) for regulatory submissions and for presentations, monographs and publications 8) Follow and participate in the ongoing development of departmental clinical SOPs as well as clinical guidelines 9) Participate and assist with the planning and organization of investigator meetings or ad hoc clinical advisory meetings (as required) 10) Maintain professional, product and market expertise via independent reading, networking, and training 11) Participate in project meetings and seminars 12) Maintain current clinical knowledge through clinical literature and attendance 13) Oversee any other projects (as assigned by Manager) 14) Develop potential applications to exploit new business opportunities 15) Perform other duties commensurate with training and experience Requirements 1) Bachelor’s degree or equivalent 2) CRA certification a plus 3) 2 – 5 years of experience as a Clinical Research Associate or Monitor 4) Medical device industry experience preferred 5) Knowledge and understanding of GCPs, medical device development process as well as regulatory pathways for clinical trials 6) Superb interpersonal skills and the ability to interact with physicians in a professional manner 7) In-depth understanding of scientific terminology along with medical and surgical practices 8) Excellent communication skills (oral and written) 9) Attention to detail and good follow-through skills 10) Willingness to travel – up to 50% (depending on the status of current projects)