PSI CRO AG is hiring a
Site Management Associate I
PSI CRO AG
π΅ ~$180k-$252k
πChile
Please let PSI CRO AG know you found this job on JobsCollider. Thanks! π
Summary
Join our international team as a Clinical Trial Associate (CTA) to support clinical research projects by streamlining communication, maintaining systems, and managing documents & information.
Requirements
- College/University Degree in Life Sciences
- Administrative work experience, preferably in an international settings
- Prior experience working as CTA for CROs
- Prior experience working in Clinical Research
- Local regulations knowledge
- Full working proficiency in English and Spanish
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
Responsibilities
- Be 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 sitesβ contact point for vendors, study supplies, and access management
- Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
- Assist 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, meaning you will need to be up to date on local regulations and dispositions
- Coordinate preparation for and follow-up on site, TMF and systemsΒ΄ 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 on-going project training for site teams in all vendor-related systems
- Document Management and translations status review of the study
- Ensure proper safety information flow with investigative sites
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