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Regional Clinical Research Associate

Company: Aerotek
Location: Germantown
Posted on: February 24, 2021

Job Description:

Description:Looking for a 2 RCRA that has a science background and understands diabetes and can hit the ground running with their diabetes medical device. The Regional Clinical Research Associate will be responsible for the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements:

  • Responsible for planning and implementing activities required to manage clinical trials and ensures that Good Clinical Practices (GCP) are followed.
  • Conduct site visits as required throughout the duration of the study, significant international and domestic travel is anticipated.
  • Train clinic sites on proper product use and operation, including hands on training on sensor insertion and removal.
  • Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors.
  • Support commercialization efforts by assisting in the development of clinical training and education materials related to the use of the product.Travel: For post approval studies, the monitoring they're doing is all remote, right now travel not as intense, but when they ramp up for IDE travel could be heavy, it will ebb and flow, there will be times when they're on the road for a week at a time, then 2 weeks out. Like Device over Pharma, but not requiredThey provide equipment, need them to start asapRequire bachelorsTop Skills Details:DiabetesMonitoring Medical DeviceAdditional Skills & Qualifications:Must have a minimum 4-year undergraduate degree in Natural Sciences or Engineering. Preferred is a graduate degree in same disciplines. Must have a minimum of 2 years of applied experience in Clinical Sciences. Preferred is 5 years' experience in implantable medical device industryMust be able to travel extensively (including international), many times on short noticeWell-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiencesExperience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Germantown , Regional Clinical Research Associate, Other , Germantown, Maryland

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