ICON Clinical Research CRA II in Raleigh, North Carolina
Clinical Research Associate II - 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 medical device, in vitro diagnostics and drug development, we hire only the best and brightest in the industry. Are you one of them?
We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
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
Performing all aspects of on site and off site (remote) monitoring activities, including SDV and SDR
Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
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 18 months of active independent field monitoring experience- all types of visits.
Knowledge of ICH GCP guidelines, medical device and/or diagnostics requirements 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.
Therapeutic experience that includes medical device and/or diagnostics products .
Why join us?
- Ongoing development is vital to us, and as a CRA II you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.