Senior Clinical Trial Coordinator
hace 4 semanas
Job Description
This position plays a key role in overseeing trial and site administration. Working closely with senior management, the individual is responsible for preparing, organizing, distributing, and archiving clinical documents. In addition, they provide vital support for clinical and non-clinical supply management, ensuring accurate tracking and reporting. Collaboration with local teams is crucial for meeting Site Ready dates and submitting necessary packages to regulatory bodies. The role involves close cooperation with various departments like COM, CRM, CRA, and finance for effective management of CTRAs and payments.
Secondary Language(s) Job Description:
Key responsibilities include, but are not limited to:
- Trial and site administration:
- Track essential documents and report Safety Reports
- Collate and distribute study tools and documents
- Update clinical trial databases and trackers
- Manage clinical and non-clinical supply in coordination with other country roles
- Oversee Labeling requirements and translation change requests
- Document management:
- Prepare, collate, distribute, and archive clinical documents
- Assist with eTMF reconciliation
- Update manuals and documents as necessary
- Ensure proper destruction of clinical supplies
- Prepare Investigator trial file binders
- Obtain translations of documents
- Regulatory and Site Start-Up responsibilities:
- Provide forms/lists for site evaluation/validation and site start-up
- Track study insurance certificates
- Support preparation of submission packages for regulatory agencies
- Publish study results as required
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 05/15/2024
A job posting remains active until 11:59:59PM on the day BEFORE the specified end date. Please ensure timely application prior to the job posting end date.
Requisition ID: R292325
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