Clinical Trial Coordinator

hace 2 días

Bogota, Colombia MSD A tiempo completo

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

**Secondary** Language(s) Job Description**:
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
1. In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
2. Obtain, track and update study insurance certificates
3. Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
4. Publish study results for GCTO and RA where required per local legislation

Document management:
1. Prepare documents and correspondence
2. Collate, distribute/ship, and archive clinical documents, e.g. eTMF
3. Assist with eTMF reconciliation
4. Execute eTMF Quality Control Plan
5. Update manuals/documents (e.g., patient diaries, instructions)
6. Document proper destruction of clinical supplies.
7. Prepare Investigator trial file binders

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R233572

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