Clinical Trial Coordinator

hace 16 horas

Bogota, Colombia MSD A tiempo completo

**Job Description**:
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.

Responsibilities include, but are not limited to:
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.

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

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

Meeting Planning:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings

Qualification & Experience:

- Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role
- Minimum 1 year of experience.

**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**:R246315

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