SiteManagementAssociate(SMA)

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. You will focus on facilitating research projects of novel medicinal products, while taking a step further in your professional career. Office-based role in Ra'anana, Israel The scope of responsibilities will include: Performs site management activities, documents and trackers management, and communication with the sites and study vendors. Site Management and Communication * Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments * Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies * Ensures regulatory and ethics committee submissions and notifications * Ensures proper administration of sites and vendors payments, as applicable * Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections * Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status * Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings * Maintains study-specific and corporate tracking systems Document Management * Maintains Trial Master File and performs TMF oversight at country/site level * Prepares, distributes, and updates Investigator Site Files and ISF checklists * Revises and checks translation status Safety Management * Ensures proper safety information flow with investigative sites CTMS Management * Updates CTMS with