Associate Clinical Sample Manager (CONTRACT)

The Opportunity:

REGENXBIO is an exceptional place where some of the best of brightest people have the opportunity to collaborate, touch amazing science, and contribute toward extraordinary plans. As a Contract Associate Clinical Sample Manager, you will be provide support and coordination of the logistical aspects of clinical sample management which includes coordinating operational activities required to collect, track, and deliver clinical trial samples for all assigned clinical trials. You’ll also support the management of vendor contracts as applicable. This is a 6-month contract position with the potential to convert to permanent.

• Assist with chain-of-custody activities for all specialty assay laboratories using the most appropriate tools (such as sample regimens, LIMS, etc.),
• Ensure collection and shipping of clinical samples from investigative sites to centralized locations (and to subsequent locations as applicable) are to plan. 
• Assist in setup and periodic review of trial related tools (templates, regimens, rosters, etc.) and reporting capabilities required per clinical sample management plans and procedures.
• Assist in sample management vendor activities as applicable, ensuring all clinical sample related deliverables are in line with the sponsor/laboratory contract and scope of work. This includes support of laboratory vendor manual, tools, as well as monitoring of vendor shipment and receipt activities, planned and actual analyses, study rosters, and sample management related issues.   
• Provide site training and guidance into the clinical trial training plan and all applicable site training materials (e.g. SIV/ IM materials, etc.). 
• Assist in the execution and implementation of vendor contracts as needed, in collaboration with applicable clinical and laboratory team members, 
• Ensure all required clinical sample deliverables are managed to completion at study closure. 
• Assist in providing budget forecasting related to clinical sample management as needed. 

• Bachelor's degree required in a scientific discipline or related healthcare field; the combination of a Bachelor's degree and experience working in the clinical research field will be considered.
• 1-2 years applicable biotech, pharmaceutical, or CRO experience; 3 is highly preferred.
• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2
• Demonstrate core understanding of medical terminology or clinical trial activities 
• Must have working knowledge and understanding of clinical protocols, and all other associated study related documents
• Advanced knowledge of MS Office including Word, Excel and Power Point and Outlook 
• Knowledge of the principles and practices of computer applications in database management
• Must have a high degree of customer focus toward internal and external stakeholders 
• Must display strong analytical and problem-solving skills
• Strong interpersonal and relationship management with the cross-functional team and external vendors skills
• Clear and concise verbal and written communication skills
• Strong attention to detail and organizational skills required
• Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines