**************************************************************
JobCircle.com is the largest regional job board in the
Mid-Atlantic region, with tens of thousands of job offerings
in PA, NJ, DE, MD, NY, and Washington D.C. To learn more,
visit
http://www.jobcircle.com?source=ng
**************************************************************
Job Title: IVRS Clinical Co-Coordinator
Job Location: NJ: East Hanover
Pay Rate: Open
Job Length: 4-6 months (contract)
Start Date: 2010-10-22
Company Name: Kaztronix, LLC
Contact: Kaz Recruiter
Phone: email only
Fax: email only
Description:
Duties:
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 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 Requirement Specifications (Functional Design Specifications) and 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 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.
Skills:
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.
Education:
BA/BS
Please refer to Job code 10-06070 when responding to this ad.
For FASTEST PROCESSING of your resume, please visit
http://www.jobcircle.com/classifieds/6899970.html?source=ng to apply online.
**************************************************************
For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
**************************************************************
FAQ
Search
Profile
Private Messages
Log in
