Clin Trials Administrator I
Clinical Trial Administrator
Home Based in the USA
In this role, the selected candidate will document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support; assist in the preparation of study and site specific materials in accordance with relevant SOPs and computer complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
Additional responsibilities include:
- Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
- Maintain the Project Directory
- Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
- Provide support to project team (e.g. proof-reading and editing correspondence, mailings,
shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.)
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
Audit and CAPA tracking
- Set up and maintain clinical investigator files and documentation
- Liaise with vendors, as needed, for study conduct such as printing study materials and/or
external systems access for study team members.
- Coordinate and plan study supply shipments with vendors
- Maintain and confirm shipment information such as courier tracking numbers and
date of shipping and delivery
- Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other
study-specific ancillary supplies (i.e. diary cards, patient visit reminders)
- Generate reports as needed, for example CTMS site contact information list
- Work with the In-House CRA and other project team members on reconciliation of data
- General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
- Perform other administrative duties as assigned by Line Manager, Project Managers or
Clinical Trial Lead.
- Bachelor's degree
- C OVID-19 vaccination required
• Experience as a Clinical Trial Assistant/Clinical Trial Administratorin the pharmaceutical industry or clinical research
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