Clinical Operations Specialist - Urgent Need

Responsibilities

• Collaborate with the Clinical Study team and Study Supply Group as required
• Aid in 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)
• Support in assembling kits, formatting and printing labels, and over-labeling in accordance with protocol and product accountability practices
• Inspect Study Product, ensuring compliance with SOP requirements
• Oversight of the storage of Study Product and Study Supplies under secure, controlled conditions that adhere to GCP and other applicable regulations and guidelines
• Aid in the disposition of product and/or supplies returned at the end of each study, including documentation, destruction, or restocking
• Aid in packaging, shipment documentation, and shipping of material (domestic and international)
• Track all inbound and outbound shipments
• Track Documentation and file 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 a highly matrix environment and thrive in a multidisciplinary team environment
• Knowledge of Good Clinical Practice (GCP), regulations, and guidance relative to the conduct of clinical trials
• Proficiency in Word Processing, Spreadsheets, and Databases
• Preferred experience in clinical trial supply handling, inventory management, and assembly of kits
• Knowledge of clinical supply planning, manufacturing, packaging, and labelling