Start-up Associate

2 semanas atrás

Cidade Jardim, Brasil Labcorp Tempo inteiro

**Main responsabilities**
- With support from a more experienced start up team member, works on low complexity studies (e.g., internal CRU or smaller external site studies in the EU and US, generally not Sponsor facing).
- Primary contact and liaison with investigative sites during study maintenance and, when assigned, site start-up (SSU) activities.
- Ensures all assigned contractually related start up site contract activities are on track and supports study deliverables.
- Reviews Investigator Packages following project and country specific regulations as well as ICH-GCP, FDA, and other regional guidance.

**Requirements**:

- University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical, or laboratory technology).
- Advanced English.
- Basic understanding of ICH Guidelines GPP and GCP including a basic understanding of regulatory requirements.
- Previous experience in clinical research.
- Basic understanding of the clinical trial process.
- Previous experience in site contracts (desirable but not mandatory)

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