Job Description

Summary

Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Clinical Study Supply Coordinator to work closely with the Clinical Project Manager and Medical Affairs teams to fulfill their study product related deliverables in conjunction with the Quality Management system SOPs and regulatory requirements. This individual will play an integral role and have responsibility for clinical study supply inventory, review, preparation, and efficient shipping of clinical trial products to contracted sites.

Responsibilities

• Collaborate with the Clinical Product Management Group as required.
• Assist with procuring study supplies, monitoring inbound shipments and accruing costs per study.
• Maintain Study Product and Study Supply inventory using Inventory management database. (Must be able to carry packages up to 30 lbs)
• Assist in assembly of kits, formatting and printing labels, over-labeling in accordance with protocol and product accountability practices.
• Inspect Study Product, including packaging and labeling per SOP and Study-specific requirements.
• Oversight of the storage of Study Product and Study Supplies under secure, controlled conditions which are compliant with GCP and other applicable regulations and guidelines, and which adhere to the required limits of temperature and humidity.
• Assist in the disposition of product and/or supplies returned at the end of each study, including documentation, destruction, or restocking.
• Assist with packaging, shipment documentation, and shipping of material (domestic and International).
• Tracking all inbound and outbound shipments.
• Tracking Documentation and filing in eTMF.

Requirements

• A minimum AAS in Science, or other Allied Health professions.
• A minimum of 1 year experience in Medical Device clinical trials, pharmaceutical, biotechnology or related firm, including direct exposure to the process of clinical study supply (IUO and Ancillary) management and execution.

Terms & Start

• Onsite 5 days/week in Bergen County, NJ
• 12 month contract
• Start ASAP
• Benefits included (Medical, Dental, Vision, and 401k options)

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