职位描述
职位描述:
Responsibilities:
1.Preparebioanalyticalmethodvalidationandsampleanalysisreportbasedonstudyrawdataandensurethereportaccuratelyreflectthebioanalyticalstudyresults.
2.InteractwithPrincipalInvestigator/StudyDirector,QAandstudymonitorfromsponsortoensurethetimelineisfollowed.Updatethereportaccordingtothecommentsfromdifferentparties.
3.Providetranslationtostudydocumentsperclientrequirements.
4.ProvidenecessarytrainingtoBASemployeesifneeded.
Qualifications:
1.MustbetrainedinorhaveexperiencewiththerequirementsofUSFDA,CFDAandOECDGLPregulations.
2.Bachelor’sdegreewithexperienceortraininginanalyticalchemistry,orequivalentexperience.
3.Mustbefamiliarwithprocessofbioanalyticalstudies.
4.Strongcommunicationskills,includingreading,writtenandverbal,andoutstandinginterpersonalskillareessentialjobrequirement.
5.Mustbeabletoopenlyshareinformationandworkinateam-orientedmannerinordertoaccomplishperformanceobjectives.