职位描述
About the Job:
As a Clinical ResearchAssociate, you will be responsible for making sure that the proper standard ofprotocol is being met at all terms of the clinical trial study, and you are toensure that the scheduled methods are being executed in the manner in whichthey should.
-Responsiblefor all aspects of study site monitoring including routine monitoring andclose-out of clinical sites, maintenance of study files, conduct of pre-studyand initiation visits; liaise with vendors; and other duties, as assigned
-Responsiblefor all aspects of site management as prescribed in the project plans
-Recruitment of potential investigators, submissions preparation, notificationsto regulatory authorities, translation of study-related documentation,organization of meetings and other tasks as instructed by supervisor
-Negotiate study budgets with potential investigators and assist the Covancelegal department with statements of agreements as assigned
-Complete Serious Adverse Event (SAE) reporting, process production of reports,narratives and follow up of SAEs
-Independently perform Case Report Forms (CRF) review; query generation andresolution against established data review guidelines on Covance or client datamanagement systems as assigned by management
Requirements:
-Minimum of four (4) years of clinical research monitoring experience (includingpre-study, initiation, routine monitoring and closeout visits)
-In lieu of the above requirements, candidates with > four (4) yearssupervisory experience in a health care setting and three (3) years clinicalresearch experience in the pharmaceutical or CRO industries (includingmonitoring) may be considered
-Have a full understanding of the Serious Adverse Event (SAE) reporting, processproduction of reports, narratives and follow up of SAEs
About Covance:
Covance Clinical DevelopmentServices is based on an integrated clinical development services that is uniqueto Covance as we are one of the few truly global drug development companiespositioned to provide comprehensive clinical support from First-in-Humanstudies through pivotal Phase III global clinical trial
At Covance, you'll discoveryour professional home to learn, grow and achieve. We offer careers with apurpose in an environment that values achievement, supports a balance betweenyour personal and professional life, and allows you to make meaningful contributionsto human healthcare.
Why Covance?
At Covance, you can make adifference by helping to deliver life-saving and life-enhancing medicines topeople around the world. Our commitment to this mission has resulted inCovance’s impressive history of company stability and growth.We’ve achieved these results by fostering a work environment thatencourages, develops and leverages our team’s capabilities.Covance’s ongoing success offers team members unsurpassed growth andcareer development opportunities. There’s no better time to join us!
