Clinical Trial Coordinator
4 days ago
Labcorp is looking to recruit a SCTA (CTC) to join our sponsor in South Africa
**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 o 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 o Assist with eTMF reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents
**REGULATORY & SITE START-UP RESPONSIBILITIES**:
- 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 were required per local legislation
**BUDGETING, AGREEMENT, AND PAYMENTS**:
- Collaborate with finance/budgeting representatives for:
- Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval, and maintenance (e.g. CTRAs)
- Update and maintain contract templates (in cooperation with the Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures,
- Budget closeout.
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