Clinical Supply Chain Specialist - 119425

Clinical Supply Chain Specialist The Clinical Supply Chain Specialist will coordinate clinical trial supplies with support of the Clinical Research Operations Department. This position will be responsible for study supplies management, supply document management, clinical study project support, and oversight of general office supplies and shipments. Key Responsibilities:Utilizing computer-based applications to maintain active inventory of all clinical investigational products and supplies in compliance with controlled procedures.Coordinate and prepare clinical study supplies such as building and packing enrollment kits, regulatory binders, shipping materials, etc. Effectively prioritize, coordinate, and time manage for multiple low to medium complexity clinical trial projects at the enrollment phase concurrently. Monitor subject enrollment kit levels at third party clinical sites and replenish materials to ensure availability at time of need. Maintain physical inventory in an organized manner that accurately reflects the locations and quantities captured in our digital inventory management system. Ship investigational product, clinical supplies, and specimens in accordance with IATA requirements.Review temperature logs and investigate temperature deviations according to protocol. Track and monitor outgoing, intra-site, and returned shipments to ensure timely arrival.Manage procurement of all clinical supply materials through established suppliers and pursue new supplier relationships as required.Monitor material availability to ensure lead time aligns with deliverables.Receive, verify, and account for all investigational products including equipment setup/calibration as needed.Adherence to the quality management system including documentation of non-conformance reports and deviations as appropriate. Accurate capture of all documentation of material traceability in trial master file in accordance with GDP. Support documentation revision to ensure current and accurate information is available. Coordinate with Clinical Operations, Site Staff, and couriers to ensure uninterrupted supply chain operations executed without error Champion continuous improvement activities (Lean Methods) to ensure scalable, efficient, and robust process flows are in place. Objective to constantly pursue team feedback to ensure best practice is implemented and team members are engaged in process improvement culture. Perform additional clinical research support, general project support, or administrative tasks as needed.Help create a fun, rewarding, and collaborative environment.Education/Skills:Associates degree; Bachelor’s degree or above preferredExperience in clinical research field; in vitro diagnostics experience is preferredUnderstanding of IATA, GCP, ICH guidelines and other clinical regulatory requirementsThorough knowledge of cold chain and other temperature-controlled shipping requirements, category B shipments, and dry ice shipmentsStrong work ethic and demonstrated ability to deliver assignments on timeAbility to handle difficult situations professionally and maintain a professional and caring demeanorAbility to lift and/or carry packages up to 50lbsReliable mode of transportation that will be used for daily drop offs at a nearby shipping location (~1 mile from office) Experience with an inventory management system Proven ability to collaborate in a team environment and work independentlyMust be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environmentMust be responsible, creative, and highly motivated