Clinical Trial Coordinator

hace 1 semana

Munro, Argentina 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.

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 (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles.
- Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable).
- Document management:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute 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: Collaborate with other country roles to:

- 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 IRB/ERC and support regulatory
- agencies submissions.
- Publish study results for GCTO and RA 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).

**Secondary** Language(s) Job Description**:
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Not Applicable

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
No

**Job Posting End Date**:
10/31/2024

**Job Posting End Date**:10/31/2024

**Requisition ID**:R314012

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