Regulatory & Site Start-Up
Quintiles Study Start Up Group ensures fast patient recruitment and start-up for both local studies and complex multi-site, multinational studies. These exciting and challenging roles will give you the opportunity to broaden your skills and experience, whilst playing an integral role in the clinical trials process.
The successful candidate will have an interest in specializing in Contracts, Site Identification, Ethics or Core Documents.
RESPONSIBILITIES (may vary)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to management on site performance metrics.
- Serve as contact for investigative sites, designated project reports, communications, and customer service.
- Work with regulatory team members or sponsor to secure authorization of regulatory documents.
- Work with legal team members or sponsor to secure authorization of contracts.
- Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
- Work with team members in preparation of regulatory submissions per work instructions.
- May participate in feasibility and/or site identification activities.
- Previous working experience in Start-up/Regulatory area
- University degree
- Strong knowledge of Microsoft Office and e-mail applications
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Fluency in Czech and English languages
Quintiles Czech Republic office is based in Nove Butovice, Prague 5.