Evolution Research Group logo
Evolution Research Group

Quality Clinical Research Today for a Healthier Tomorrow

CRO – Clinical Trials Assistant

Conversion Rate OptimizerConversion Rate OptimizerFull TimeRemoteMid LevelTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

25 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

CRO – Clinical Trials Assistant

Evolution Research Group

• Support Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • Archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence. • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. • Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc. • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release. • Assist in the preparation and development of study-specific training materials. • Participate in the planning of investigator meetings. • Interact with sites as needed to respond to issues. • Handle incoming and outgoing shipments, as needed. • Monitor and track monitoring visit reports. • Collect enrollment updates and reports on a weekly basis. • Assist PM with set up and preparation of project meetings.

Job Requirements

  • BS/BA preferred.
  • High school diploma/certificate or educational equivalent required.
  • Minimum of 2 years of clinical research experience required; one year CTA experience preferred but not required.
  • Must possess a general knowledge of applicable clinical research requirements, including GCP and ICH guidelines.
  • Demonstrated organizational and coordination skills with attention to detail.
  • Solid understanding of clinical drug development is preferred.

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