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ICON Clinical Research Senior CRA in Boston, Massachusetts

Senior Clinical Research Associate - Medical Device

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

As a Senior Clinical Research Associate at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

The role

  • Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation

  • Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested

  • Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required

  • Managing sponsor generated queries efficiently and responsible for study cost effectiveness

  • Dependent on level of experience you may assist in training and mentoring less experienced CRA's and/or manage CRA's working on international projects

What you need

  • Minimum of 3 years of active independent field monitoring experience- all types of visits.

  • Minimum 2 years of medical device experience

  • Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data

  • Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner

  • Ability to produce accurate work to tight deadlines within a pressurized environment

ICON Plc is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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