The global CRO where clinical trials run on time.
Site Management Associate
Location
Brazil
Posted
1 day ago
Salary
0
Seniority
Mid Level
Job Description
Site Management Associate
PSI CRO AG
• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion • Serve as the primary site’s contact point for vendors, study supplies, and access management • Ensure that pre-study testing of local site facilities is completed • Assists the Monitors in their prompt completion of all subject event and site event information in CTMS • Track the resolution status of site issues and action items in CTMS • Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies • Ensure regulatory and ethics committee submissions and notifications • Coordinate preparation for and follow-up on site, TMF and systems' audits and inspections • Manage the TMF on a site and a country level for regularly and file documents • Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists • Arrange and track initial and ongoing project training for site teams in all vendor-related systems • Document Management and translations status review of the study
Job Requirements
- College/University Degree in Health Sciences
- Administrative work experience
- Prior experience working in Clinical Research
- Local regulations knowledge
- Full working proficiency in English and Portuguese
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
Benefits
- Professional development
- Remote work options
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