- Manage 2–3 clinical trials and assigned site management activities.
- Assist with site selection, evaluation, initiation, and collection of pre-study documentation.
- Train site staff in study procedures and develop training materials with the Training & Qualification Management Unit.
- Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports.
- Review Case Report Forms for accuracy, legibility, completeness, and quality.
- Conduct source data verification and in-house clinical data review, and resolve data queries in a timely manner.
- Manage investigational products and trial materials, including the Investigator Study File and CRFs.
- Coordinate site reporting and follow-up for adverse events and other safety issues.
- Conduct study termination and closeout activities, including archiving, and act as the site's main contact.
- Support study preparation, CRF development, site budget negotiations, submission activities, and CRA I coaching.
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