[Z251] SITE MANAGEMENT ASSOCIATE I

**company overview** we are psi-cro, a dynamic and global company that cares about our staff, clients, partners, and the quality of work we do. founded in 1995, we bring together over 2,800 dedicated and passionate individuals who work on the frontline of medical science, changing lives and bringing new medicines to those who need them. about the role as a clinical research coordinator, you will be the key support to clinical research projects, streamlining communication, maintaining systems, and managing documents and information. you will be responsible for: - being the main point of contact between site personnel and cra involved in the project, helping with query resolution and edc completion. - serving as the primary sites' contact point for vendors, study supplies, and access management. - ensuring pre-study testing of local site facilities is completed, including scans, mri/ct qualification questionnaires, test ecgs, etc. - assisting monitors in completing all subject event and site event information in ctms. - tracking the resolution status of site issues and action items in ctms. - ensuring regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations and dispositions. - coordinating preparation for and follow-up on site, tmf, and systems audits and inspections. - managing the tmf on a site and country level, regularly filing documents. - preparing, distributing, and updating investigator site files (isf) and isf checklists. - arranging and tracking initial and ongoing project training for site teams in all vendor-rela...