Clinical Research Associate / CRA Manager (19-00675) – MA – Newton

A minimum of 5 years’ experience as a Clinical Research Associate or an equivalent position, with particular skills and knowledge working on clinical trials following FDA/ICH guidelines. Must have experience as a field-based monitor.

This position is an in-house position with an up to 50% travel component. This position will help manage a team of field-based contract CRAs for a multi-site study and will be the primary field CRA for some clinical sites.

This position reports to the Sr. Director of Clinical Affairs.

  • Serve as liaison with participating clinical research sites, including, but not limited to, physician investigators, research nurses, and study coordinators
  • Conduct on-site and remote monitoring as needed
  • Oversee scheduling and compliance to Monitoring Plan with the field CRA team
  • Review field CRA monitoring reports and report trends, problems, and solutions to study team
  • Triage and escalate clinical study issues as needed
  • Support clinical research study start-up activities, including training material development, delivery, and documentation
  • Function as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/preventive solution development.
  • Train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, data entry and query resolution
  • Oversight of Trial Master File and Essential Documents. Experience with electronic Trial Master Files preferred.
  • Have a strong understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines.
  • Excellent and demonstrated oral and written communications.
  • Device experience preferred

Source: Job Diva – Job Listing

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