Clinical Research Site Report Specialist社

10K-15K/月

市辖区

发布时间：2023-09-06

职位描述

职位描述：

TheSiteReportSpecialist(SRS)jobroleistoreviewandapproveClinicalResearchAssociate(CRA)SiteVisitReports.TherolescanbebasedinBJ/SHorremotecity.
Reviewandapprovaloftimely,highqualityandconsistentfinalSVRsasperspecificannotations
MentorCRAsandprovidesupportinthecompletionofSVRsandassistanceCRAsinidentifyingissues
IssuereminderstoCRAsforfinalreportsubmittalandcompliance
Meetregularlywiththestudymanagementteamtodiscussstudy-relatedissuesandtrendingofissues
ProvidequalityoversightbyfunctioningasQualityChampionsforCSMQMandprojectteams
Supplyrelevant,current,andongoinginformationtosupportCSMQMandCTL/CPM’sprospectiveandproactiveassessmentsofkeyriskindicators
Activelysupporttheprojectteamintheprocessesaroundtheidentificationofnon-complianceandtheneedforimplementationofCorrectiveActionPlans(CAPs)
Understand,apply,andmaintaincompliancetoICH/GCPs,SOPs,andprojectrequirements


REQUIREDKNOWLEDGE,SKILLSANDABILITIES
CRAs/ACPM/CRSwith100-150sitemonitoringexperiencewith1-2yearsofreportsreviewexperience
StrongwrittenandverbalcommunicationskillsincludinggoodcommandofEnglishlanguage
AdvancedknowledgewithrelevantworkexperienceinClinicalResearch.
Strongplanningandmanagementskills(shouldbeabletoself-managed).
GoodknowledgeofGCPandclinicaltrialmanagement.
Shouldbeabletoworkinflexibletimezones.Shouldpossessgoodleadershipqualities
Proactiveandworkedunderdemandingtimelines,pressure;
Organizingandexecutionskills;
Positiveattitudewithgoodinterpersonalskills;
Desirabletohaveglobalworkexperienceinclinicalresearchfield

MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
Bachelor'sdegreeinlifesciencesorrelatedfieldandmin4yearswithrelevantclinicalresearchexperience;orequivalentcombinationofeducation,trainingandexperience

其他要求

招聘人数：1人
职能类别：数据库建设

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。