Clinical Trial Associate; Drug Safety Associate

Pharmaceutical Professionals Zenith Lifescience LLC has multipleopenings in So. Plainfield, NJ & otherunantcptd locns nationwide for positionsrequiring min 1 yr of relevant exp, to perform duties the following duties: Clinical Trial Associate Coord & documt internal regulatoryprocesses for pharmal clinical studies. Prepare site regulatory documts,eCRFs, paper CRFs, & Clinical Trial Agreements. Support clinical trialsupply & infectious disease sampleshipments while adhering toregulatory standards. Evaluate suppliers, analyze price proposals,& maint records of purchased items,costs, & inventories. Draft protocol& ICF documts, submit to IRB/EC,& respond to queries. Coord w/datamgmt team to clean & transform rawdata for analysis. Maint & updateclinical study documents using eTMF. Drug Safety Associate Coord & documt internal regulatoryprocesses for pharma clinical studies.Receive, evaluate & report SeriousAdverse Event (SAE) reports fromclinical trials. Submit SAE reports toregulatory agencies. Perform qualityreview of Adverse Event data entry,MedDRA, WHO-Dictionary coding, Narratives & labeling of cases.Assist validation dept by authoring& executing scripts for safetydatabase upgrades. All positions require a Mstrs deg orequiv in Sci, Engg, Pharma orrltd field w/min 1 yr relevantexp. Sal: $98,384. Travel/reloc reqdto various unantcptd client work locns nationwide for long or short durations & unknown freq. Mail 2 copies of resume& proof of work eligibility to: Zenith Lifescience LLC, 51 Cragwood Rd, Suite 306,South Plainfield, NJ 07080
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