Responsibilities include, but are not limited to:
- Assist in the preparation Of project and study-related documents including: Investigator’s Brochures, Protocols, Informed Consent Forms, Monitoring Plans, and Study Manuals, as required.
- Assist with coordination of Case Report Forms (CRF) and CRF Guidelines, including participating in The Electronic Data Capture (EDC) user acceptance testing.
- Assist in the review of clinical data in EDC and data listings/reports.
- Assist in the coordination of the preparation of clinical contracts and site budgets.
- Assist in monitoring and tracking clinical trial progress and providing status update reports, study metrics, and regulatory documents.
- Assist in vendor support activities.
- Assist in the planning of investigator meetings and presentations, as required.
- Prepare meeting agendas and minutes.
- Facilitate mass study communications.
- Support department training needs and documentation. Create training, review, and approval workflows for new and/or updated SOPs. Track training through the Training Matrix.
- Maintain www.clinicialtrials.gov website for all studies.
- Support department with shipments of study documents, supplies, and mass communications to sites as needed.
- Support Clinical Operations Department for administrative tasks and projects.