Description
Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery.
Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems.
- Prepare, handle, distribute, file, and archive clinical documentation and reports.
- Review study files for completeness.
- Assist CRAs and RSU with Clinical Trial Supplies and tracking information.
- Act as a central contact for the clinical team for project communications.
- May accompany CRAs on site visits to assist with clinical monitoring duties.
Qualifications
- High School Diploma or equivalent.
- 3-4 years administrative support experience.
- Equivalent combination of education, training and experience.
- Minimum one year clinical research experience strongly preferred.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.