Description
Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery.
Responsibilities:
- 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 with Clinical Trial Supplies and tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- 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 required.
- 3 years administrative support experience.
- Computer skills including Microsoft Word, Excel, and PowerPoint.
- Good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships.
- Awareness of clinical research regulatory requirements (GCP and ICH guidelines).