Site Management Associate I

Responsibilities

• Act as the main point of contact between site personnel and CRAs to assist with query resolution and EDC completion
• Serve as the primary contact point for vendors, study supplies, and access management
• Ensure pre-study testing of local site facilities is completed
• Assist Monitors with subject and site event information in CTMS and track resolution status of action items
• Manage the order, receipt, inventory, distribution, and reconciliation of clinical supplies
• Ensure regulatory and ethics committee submissions and notifications comply with local regulations
• Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections
• Manage the TMF at site and country levels and maintain Investigator Site Files (ISF)
• Arrange and track project training for site teams in vendor-related systems
• Review document management and translation status for the study
• Ensure proper safety information flow with investigative sites

Requirements

• College/University Degree in Life Sciences
• Administrative work experience, preferably in an international setting
• Prior experience working as a CTA for a CRO
• Prior experience working in Clinical Research
• Knowledge of local regulations
• Full working proficiency in English
• Proficiency in MS Office applications
• Strong communication, collaboration, and planning skills

About the Company

PSI CRO is a dynamic, global company founded in 1995. We are a team of more than 2,800 dedicated individuals working on the frontline of medical science to bring new medicines to those who need them. We pride ourselves on being a company that cares for our staff, our clients, our partners, and the quality of our work.