Clinical Research Regional Monitor

AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.As a Clinical Research Regional Monitor, you will implement and carry out monitoring functions for clinical research studies. This position can be located in Washington, DC or Raleigh, NC. Follow department Standard Operating Procedures. Schedule and conduct monitoring activities at assigned centers assessing site compliance to the clinical investigation plan, regulations and GCPs. Discuss monitoring visit findings with site personnel and complete written report. Identify and track monitoring action items, verifying corrective actions and resolutions. Work independently on specific study projects. Assist in Site Initiation Visits at study sites. Acquire professional, product and market expertise via independent reading, networking and training. Act as a resource and train other clinical study team members. Travel approximately 50 - 70% (as project needs require). Participate in professional activities outside of normal business hours. Qualifications: BA/BS in Medical Science, Nursing or related field. 2+ years experience in clinical research monitoring, preferably medical device company. Knowledge of clinical research study processes and study design and ability to incorporate and adhere to Good Clinical Practices, regulatory standards. Computer proficiency required: Database Systems, Word, Excel, Access, PowerPoint, internet, email. Ability to produce professional correspondence, presentations, reports and training materials. Ability to recognize reportable adverse events when reviewing patient charts, ensuring that proper IRB/FDA requirements have been followed. Ability to constructively interact with a range of personalities and positions both inside and outside of the organization. Attention to detail. Ability to organize, prioritize, and manage tasks in a changing environment. Ability to work independently, seek out assistance when needed and take direction from others. Willingness to participate on a team and adapt as necessary to achieve goals/milestones and ensure success. Current, valid driver’s license. -For quick consideration apply here We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more. An Equal Opportunity/ Affirmative Action Employer Please, No Agencies Position Information Location: Washington, DC Job Category: Biotech/R&D/Science Contact Information reference code: 1111