Clinical Analyst (In-house CRA)- Global Top CRO社

8K-10K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

ClinicalAnalyst(In-houseCRA)
 
在远程临床研究监察中心(CentralizedClinicalOperation)模式下，参与global/regional 大型临床研究，并对以下等方面提供远程支持。
 
负责不同国家on-site临床监察员出差前的准备工作
负责解决可远程操作的ActionItem
负责相关电子文档的审阅
 
职位要求：
1.5年以上CRA/CRC等临床研究领域相关工作经验，或具有相关领域知识背景，本科以上学历。
英语四，六级或具有第二语言特长。
良好的沟通能力
熟练使用office相关办公软件

PURPOSE
Applyclinicalresearchexpertisetoprovideprojectrelatedassistanceacrosscomplexandmultiple project(s),sitesandprojectteams.Leadteamsfunctionally,whereassigned,includingawarenessofscopeofwork,budget,andresources.EnsureallworkisconductedinaccordancewithSOPs,policiesandpractices,goodclinicalpracticesandapplicableregulatoryrequirementsandmeetsqualityandtimelinemetrics.?

RESPONSIBILITIES
Performcomplexprocessesandtasksthateventuallyresultinhighqualitydeliverablesthatarecompletedaccordingtoservicelevelagreements(SLAs)andwithinprojecttimelines 
Establishandmaintaineffectiveproject/sitecommunications
Createandmaintainrelevantprojectdocuments//trackers
Ensureaccuratecompletionandmaintenanceofinternalsystems,databases,trackingtools,timelinesandprojectplanswithprojectspecificinformation  
Review,evaluateandrecommendmodificationstodesignatedprocesses
Overseeandparticipateindocumentmanagement(creation,review,maintenance,storage,asapplicable)
Participatein(study)teammeetingsandimplementactionitems
Collaboratewiththeprojectlead/teammembersincreation/reviewofstudydocuments
Actaspointofcontactforassigneddeliverablesforspecificcustomersorprojects
Evaluatethequalityandintegrityofstudysitepracticesrelatedtotheproperconductoftheprotocolandadherencetoapplicableregulations.
Escalatequalityissuestorelevantstakeholdersand/orlinemanager.
 
REQUIREDKNOWLEDGE,SKILLSANDABILITIES
Advancedknowledgeofclinicaltrialconduct,andskillinapplyingapplicableclinicalresearchregulatoryrequirements;
    i.e.,ICHGCPandrelevantlocallaws,regulationsandguidelines,towardsclinicaltrialconduct.Familiaritywithrelatedsystemsandsoftwareutilizedinclinicaloperations.  
StrongwrittenandverbalcommunicationskillsincludinggoodcommandofEnglishlanguage   
Resultsanddetail-orientedapproachtoworkdeliveryandoutput    
Goodproblemsolvingskills 
Goodplanning,timemanagementandprioritizationskills
Abilitytohandleconflictingpriorities     
Attentiontodetailandaccuracyinwork
Goodsoftwareandcomputerskills,includingMSOfficeapplicationsincludingbutnotlimitedtoMicrosoftWord,ExcelandPowerPoint   
Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients.
ProvenabilitytoworkonmultipleprojectsbalancingcompetingprioritiesGoodleadershipskills
Abilitytoworkacrossculturesandgeographieswithahighawarenessandunderstandingof culturaldifferences       
MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
Bachelor'sdegreeinlifesciencesorrelatedfieldandmin3yearswith relevantclinicalresearchexperience;orequivalentcombinationofeducation,trainingandexperience

其他要求

招聘人数：1人
职能类别：临床协调员CRC

公司介绍

昆泰公司简介

昆泰是全球最大的生物制药服务企业（2011年净收入超过30亿美元），并且是全球范围内唯一一家可以提供全方位的临床、商业、咨询及投资解决方案的生物制药服务企业。昆泰公司覆盖80个国家，拥有达2.7万名员工。