Senior Site Management Associate

Senior Site Management AssociateFull-timeCompany DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job DescriptionThe scope of responsibilities will include:Main site contact for all non-trial-participant related and non-protocolrelated issues, including vendors, trial supplies and access managementManages records flow with sites and off-site facilitiesPrepares regulatory and ethics committee submission/ notificationdocuments 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 andsitesReviews site-specific EDC completion progress and provides the Monitorwith regular updatesServes as the main contact point for other company departments inadministrative site-related issuesOrganizes, participates in, and prepares reports of internal project teammeetingsCollaborates with sites and project team on Investigator Meetings'organizationUnder supervision, provides on-the-job coaching of Site ManagementAssociates I & II and Clinical Operations Administrative Support staffArranges and tracks initial and ongoing trial training for investigator siteteams in all vendor-related systemsProvides training in courier management and trial supplies ordering to theinvestigator 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 ISFchecklistsCoordinates the translation process for trial records on a site and countrylevelCollects IP-REDs and compiles IP-RED packages for further reviewMain vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systemsTracks vendor-related supplies on a site, country/regional levelExchanges information and records with vendorsQualificationsCollege or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.Minimum 3-year experience within the clinical research industry, CRO preferred, in similar role or equivalent to Site Management Associate IIBasic proficiency in MS Word.Basic proficiency in MS Excel.Basic proficiency in MS Outlook.Basic proficiency in MS Power Point.Knowledge (following proper training) of applicable software and project specific systems.Additional InformationBecome a full-fledged clinical research professional with the support of a knowledgeable and professional team.  You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice