Clinical Research Associate Ii

19 ore fa

Lazio, Italia Coinstar Tempo pieno

Clinical Research Associate II / Senior Clinical Research (CRA) - ItalyJob Category: Clinical MonitoringRequisition Number: CLINI**Posted : October 1, ****Full-TimeRemoteLocationsShowing 1 locationItaly - RemoteDescriptionWhatYou'llDo: Serve as main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with or oversee study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings; may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project TeamWhatYou'llBring:3 - 5 yearsclinical research experience as a CRA or related professionLife science backgroundExcellent knowledge in ICH-GCP and regulatory requirementFluent (at least Level B2) in spoken and written language - EnglishAboutCTIAdvanceYourCareer–Weinvestinyourprofessionalgrowth.
Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.
Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.
JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.
Wesupportyourwork-lifebalancewithhybridworkopportunities.
ThroughourCTICaresprogram,you'llhaveopportunitiestogivebacktoyourcommunityandtheworld.
MakeaLastingImpact–AtCTI,yourworkdirectlycontributestoadvancingmedicine.
You'llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.
Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.