Description
Responsibilities:- Set up CTMS system, as appropriate
- Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations
- Handle incoming and outgoing shipments, as needed
- Assist with all aspects of initial study drug release including regulatory packet review and study-drug release
- Assist in the preparation of study-specific training materials
- Participate in the planning of investigator meetings
- Assist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriate
- File clinical documents and maintain clinical research files (ie, central files for studies)
- Participate in support of regional Field Monitors
- Interact with sites as needed to respond to issues
- Monitor and track ALL monitoring visit reports (per CTMS)
- Assist with tracking of clinical trial progress including status update reports, as required
- Participate in the review of clinical data at the case report form, data listing, and report table levels
- Assist with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, IND Annual Updates, NDAs, and other documents, as required
- Participate in clinical teams, including attending required meeting, and interact in a positive, professional manner
- Maintain training update to date including review and sign off of SOPs
- Identify and escalate issues appropriately
- Perform other duties as assigned
- Set up clinical trials in 'Clinicaltrial.gov' and maintain until end-of-study
Requirements:
- BA/BS in scientific discipline is highly preferred, but not required
- 2 years + experience in the pharmaceutical/clinical research environment
- Able to prioritize and handle multiple tasks simultaneously
- Must have demonstrated expertise in relevant clinical operations activities
- Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
- Working knowledge of ICH/GCP guidelines and FDA regulations