Clinical Study Supply Coordinator

Responsibilities

• Collaborate with the Clinical Study team and Study Supply 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)
• Absorb kits, format and print labels, over-label in accordance with protocol and product accountability practices
• Inspect Study Product, including packaging and labelling per SOP 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
• Absorb the disposition of product and/or supplies returned at the end of each study, including documentation, destruction, or restocking
• Absorb packaging, shipment documentation and shipping of material (domestic and International)
• Track all inbound and outbound shipments
• Track Documentation and filing in eTMF

Requirements

• A minimum AAS/BA/BS in Science, Engineering, Pharmacy, or other Allied Health professions
• Highly organized, detail oriented, and creative
• Excellent interpersonal skills
• Ability to perform under highly matrix environment, and able to thrive in a multidisciplinary team environment
• Knowledge of Good Clinical Practice (GCP), regulations and guidance relative to the conduct of clinical trials
• Proficient in Word Processing, Spreadsheets and Databases
• Clinical Trial supply handling experience is preferred
• Demonstrate experience in working on inventory management, and assembly of kits. Knowledge of clinical supply planning, manufacturing, packaging, and labelling
• Must be computer savvy, detailed oriented, fast learner, multi-task. Database experience a must