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For your reference, we have included the original job posting below.
IVRS Clinical Coordinator 8
Job Number:
26841720
Company Name:
Sunrise Systems Inc
Job Location:
East Hanover, NJ US
Job Category:
IVRS Clinical Coordinator 8
Our major pharmaceutical client is looking for an IVRS Clinical Coordinator for a 6+ month position in Morris County, ition Description:- As the centralized IVRS expert the IVRS Clinical Coordinator (ICC) evaluates planned trials as potential IVRS candidates. - Once a trial is identified the ICC closely liaises with, and supports the Clinical Trial Team (CTT) and Drug Supply Management (DSM) in the selection of the IVRS provider, sharing IVRS expertise with the CTT. - Once the provider has been selected the ICC supports the CTT in the completion of the User Requirement Specifications, and other relevant activities for IVRS initiation. - The ICC ensures approval of the documents in a timely manner by both DSM and CTT and supports CTT and DSM during the trial with respect to any IVRS issues arising. - Identify trials that are potential candidates for IVRS based on information from the clinical trial team (CTT) if possible 6 months before study start. - In close conjunction with the CTT and CRO management complete the SSW and request costing proposals from potential suitable vendors. - Check proposal reflects services requested/needed for trial; prepare overview of proposals received to facilitate vendor selection by CTT. - Provide IVR and logistic expertise to CTT and vendor in order to finalise the User Requirement Specifications (Functional Design Specifications) and User Documentation. - Ensure all documents are finalized and approved in a timely manner for study start-up and adhere to the established IVRS Design Standards. - Ensure team is aware of the implication of system facilities which impact upon other internal systems. - Ensure established standard procedures with vendors are adhered to. - Discuss and resolve where necessary any GCP/GMP/QA issues with relevant line functions. - Perform and document user acceptance testing (UAT), of all systems and report facilities with support of CTT prior to system go live and after any critical programming changes after go live. - Act as the main contact point for country depot, CTT, and vendor for troubleshooting, dealing with complaints and issues in order to achieve optimal use of the system for ongoing studies. - Review / monitor, in an unblinded fashion if necessary, drug stock levels and patient recruitment. - Highlighting potential issues to (blinded) CTT and Drug Supply Management (DSM) in order to optimally allocate and utilize restricted resources. - Support budget forecasting and invoicing processes in conjunction with CRO Contract Management group. Requirements:- Bachelor's degree required-Professional Experience: 3-5 years experience in Pharmaceutical / Clinical Development Operations / Drug Supply Management. - Good communication and networking skills - Excellent interpersonal organisation and planning skills - Knowledge of the clinical protocol design and GCP - Good understanding of regional clinical research practice - Familiar with standard computer office software and ability to easily learn special software packages - Fluent in spoken and written English - Good understanding of the clinical development drug supply chain. - Professional Experience: 3-5 years experience in Pharmaceutical / Clinical Development Operations / Drug Supply Management. Qualified candidates should please send a MS Word copy of their resume to . PLEASE INCLUDE THE JOB REF # IVRS-EHNJ IN THE SUBJECT LINE! Apply directly at:
