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Clinical Supply Coordinator

Company Name:
Belcan
Clinical Supply Coordinator
Job Number: - Added 8/20/2007, EM -> 192070
Category: A - Immediate/Urgent Need
Description:
Clinical Supply Coordinator
Our client in Whippany, NJ has an immediate need for a Clinical Supply Coordinator!
Job Description
Member of extended Study Team
Revises / develops the clinical study protocol regarding identity of study drugs including possible comparators, medical devices, randomization and blinding
Ensures proper supply of study medication for all patients in a clinical trial. Monitors and assesses clinical supply demands to ensure clinical and clinical supply requirements are met. Responsible for the supervision of the distribution of clinical supplies from central to local depots and from depots to sites
Responsible and accountable for the process of assessment of the usage of study medication that has been affected by a temperature excursion at site, in co-operation with the Quality-Function, to make certain that no drug whose pharmaceutical quality has been affected negatively can be taken by patients.
Responsible for expiry date tracking of study medication on the study level and taking of appropriate action in case of study drug expiration to exclude any potential harm of patients caused by taking expired medication. If the shelf life of a batch of study medication can be extended the cPharm initiates and supervises the process of labeling of medication packs with the new expiry date in accordance with the applicable GMP regulations and legal requirements.
Supports drug accountability and supports monitors in destruction of study medication at site.
Leads the Interactive Voice/Web Recognition System (IxRS) cross-functional sub-team, who has the responsibility for the setup and maintenance of the IxRS System. The cPharm is accountable for the selection, setup and maintenance of the IxRS System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol.
Responsible for providing guidance and training to study teams, monitors and site personnel on the handling of study medication and the IXR System.
Share knowledge and experiences within GCDO and other relevant stakeholders
Survey and assess new regulatory developments and develop implementation plan to address new requirements,
Ensure Compliance with all relevant SOP's, GMP, GCP and ICH guidelines, as well as with legal and ethical standards
Immediate long-term contract opportunity with an outstanding client! Please send resume, references, and salary requirements to Colleen at .
Requirements:
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the technical, IT, professional, clerical, and light industrial fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website .
Location: Whippany , NJ
Minimum Experience (yrs): 5+
Required Education: Bachelor (BA, BS...)
Benefits:
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