Start-up Associate

hace 1 semana


Buenos Aires, Argentina Labcorp A tiempo completo

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 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:

- 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
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
- Working knowledge of Contract development, negotiation, approval and maintenance (e.g. CTRAs)
- Update and maintain contract templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures
- Budget closeout.
- Obtain and process FCPA documentation in a timely manner
Meeting Planning:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where
applicable

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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