Clinical Trial Coordinator

5 days ago

Pretoria, South Africa Parexel Full time

Parexel FSP has an exciting opportunity for an experienced Clinical Trial Coodinator to join our sponsor dedicated function. The CTC is expected to work from the sponsor office in Johannesburg.

In this role you will be supporting the study manager and wider study teams from start up to close out.

**Responsibilities**:
**Trial and site administration**:**
- Tracking (e.g. essential documents) and reporting (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

**Document management**:**
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with electronic Trial Master File (eTMF) reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Execute eTMF Quality Control Plan
- Obtain translations of documents

**Regulatory & Site Start Up responsibilities**:

- Provide 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 Global Clinical Trial Operations and Regulatory Affairs where required per local legislation

**Budgeting, Agreement and Payments: Collaborate** with** finance/budgeting representatives** for**:

- Development of country and site budgets (including Split site budget)
- Tracking and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval, and maintenance
- Updating and maintenance of contract templates (in cooperation with Legal Department)

**Education**
- B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience
- 1-2 years' experience as a minimum supporting clinical trials
- 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

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