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.

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.

CRO – Clinical Trials Assistant

Key skills