Site Management Associate II

Start your career in clinical research, streamlining communication, maintaining systems and managing documents.The scope of responsibilities will include:Main site contact for all non-trial-participant related and non-protocol

related issues, including vendors, trial supplies and access managementManages records flow with sites and off-site facilitiesPrepares regulatory and ethics committee submission/ notification

documents and recordsCoordinates payments to sites and off-site facilitiesPrepares for and follows up on site audits and inspectionsReviews and coordinates site-specific query resolution with Monitors and

sitesReviews site-specific EDC completion progress and provides the Monitor

with regular updatesServes as the main contact point for other company departments in

administrative site-related issuesOrganizes, participates in, and prepares reports of internal project team

meetingsCollaborates with sites and project team on Investigator Meetings'

organizationUnder supervision, provides on-the-job coaching of Site Management

Associates I and Clinical Operations Administrative Support staffArranges and tracks initial and ongoing trial training for investigator site

teams in all vendor-related systemsProvides training in courier management and trial supplies ordering to the

investigator sitesFiles trial records in the TMF and performs regular TMF checks on a site and country levelParticipates in and follows up on TMF and systems auditsPrepares, distributes, and updates Investigator Site Files (ISF) and ISF

checklistsCoordinates the translation process for trial records on a site and country

levelCollects IP-REDs and compiles IP-RED packages for further review