
Clinical Trial Coordinator
2 semanas atrás
About the Role:
We are seeking a highly skilled professional to lead our clinical trials and surveillance efforts. As a key member of our research team, you will play a critical role in ensuring the safety and efficacy of our products.
This position involves comprehensive trial and site administration, including preparation, collation, distribution, and archiving of clinical documents. You will be responsible for meeting planned Site Ready dates, which includes assisting with the preparation of submission packages to IRB/ERC and Health Authorities.
The responsibilities include:
- Regulatory & Site Start-Up responsibilities;
- Collaborating with cross-functional teams;
- Providing and collecting forms/lists for site evaluation/validation, site start-up and submissions;
- Tracking and updating study insurance certificates;
- Supporting preparation of submission package for IRB/ERC and regulatory agencies submissions;
Key Requirements:
- Bachelor's degree;
- Excellent English language skills;
- Strong understanding of Global, Country/Regional Clinical Research Guidelines;
- Hands-on knowledge of Good Documentation Practices;
- Advanced Microsoft Office Excel skills required;
- Superior negotiation and communication skills;
- Effective time management, organizational, and interpersonal skills;
- High sense of accountability and urgency;
- Ability to set priorities and handle multiple tasks simultaneously;
- Works effectively in a matrix multicultural environment;
- Demonstrates commitment to Customer focus;
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