Site Management Associate I

Hybrid role in King of Prussia, PASite ManagementEnsures exchange of information and documentation with sites and vendorsEnsures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical suppliesEnsures regulatory and ethics committee submissions and notificationsEnsures proper administration of sites and vendors paymentsCoordinates preparation for and follow-up on site, TMF and systems´ audits and inspectionsReviews and coordinates site-specific query resolutionReviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion statusOther CommunicationExchanges information and documentation with other departmentsSupports the organization of internal team meetings including preparation of agendas and minutesSupports the organization of Investigator MeetingsMaintains study-specific and corporate tracking systemsServes as the sites’ primary contact pointServes as the primary sites’ contact point for vendors, study supplies, and access managementEnsures communication between the sites and off-site facilitiesTrainingArranges and tracks initial and on-going project training for site teams in all vendor-related systemsProvides training in courier management and study supplies ordering to the site teamDocument ManagementChecks the TMF on a site and a country level regularly and files pending documentsPrepares, distributes, and updates Investigator Site Files (ISF) and ISF checklistsProvides Monitors with ISF documents to be filed in the ISF prior to each monitoring visitRevises and checks translations statusSafety ManagementEnsures proper safety information flow with the investigative sites.CTMS ManagementUpdates CTMS with lacking project informationAssists the Monitors in their prompt completion of all subject event and site event information in CTMSAssists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMSTracks the resolution status of site issues and action items in CTMSVendor ManagementEnsures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completedTracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site levelOther departmental assignments, as necessary