
1001 - 5000 employees
Founded 1996
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
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1001 - 5000 employees
Founded 1996
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
• 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 sites’ contact point for vendors, study supplies, and access management • Ensure pre-study testing of local site facilities is completed, including scans, MRI/CT qualification questionnaires, and test ECGs • Assist Monitors in prompt completion of subject event and site event information in CTMS • Track the resolution status of site issues and action items in CTMS • Ensure the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies • Ensure regulatory and ethics committee submissions and notifications, staying up to date on local regulations and dispositions • Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections • Manage the TMF on a site and country level and regularly 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 vendor-related systems • Review document management and translation status of the study • Ensure proper safety information flow with investigative sites
• Only CVs in English will be accepted • 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 • Proficiency in MS Office applications • Ability to plan and work in a dynamic team environment • Communication and collaboration skills
• Employees can work remotely • Advance your career in clinical research • Coordinating a variety of tasks and learning new things while growing with the company
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