Clinical Trial Associate; Drug Safety Associate

Pharmaceutical Professionals Zenith Lifescience LLC has multiple openings in So. Plainfield, NJ & other unantcpt'd locns nationwide for positions requiring min 1 yr of relevant exp, to perform duties the following duties: Clinical Trial Associate Coord & documt internal regulatory processes for pharmal clinical studies. Prepare site regulatory documts, eCRFs, paper CRFs, & Clinical Trial Agreements. Support clinical trial supply & infectious disease sample shipments while adhering to regulatory 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/data mgmt team to clean & transform raw data for analysis. Maint & update clinical study documents using eTMF. Drug Safety Associate Coord & documt internal regulatory processes for pharma clinical studies. Receive, evaluate & report Serious Adverse Event (SAE) reports from clinical trials. Submit SAE reports to regulatory agencies. Perform quality review of Adverse Event data entry, MedDRA, WHO-Dictionary coding, Narratives & labeling of cases. Assist validation dept by authoring & executing scripts for safety database upgrades. All positions require a Mstr's deg or equiv in Sci, Engg, Pharma or rltd field w/min 1 yr relevant exp.

Sal:

$98,384. Travel/reloc req'd to various unantcpt'd 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