**Responsibilities include, but are not limited to**:
- Trial and site administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases and trackers
- Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eletronic Trial Master File (eTMF)
- Assist with eletronic Trial Master File (eTMF) reconciliation
- Execute eletronic Trial Master File (eTMF) Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
- Regulatory & Site Start-Up responsibilities:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for Ethics Committee and support regulatory agencies submissions.
- Publish study results for Global Clinical Trial Operations and Regulatory Authority where required per local legislation
Meeting Planning:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Required Skills**:
Adaptability, Clinical Information Systems, Clinical IT, Clinical Research Management, Clinical Study Design, Clinical Testing, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Customer-Focused, Data Analysis, Document Management, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, Meeting Management, Meeting Organization, New Technology Integration, Project Management, Publishing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Management, Regulatory Submissions, Translations
**Preferred Skills**:
**Job Posting End Date**:
07/20/2025
**Requisition ID**:R357196