Job Description

Overview REGENXBIO is an exceptional place to work. You\'ll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities. The opportunity As a Clinical Research Associate (CRA), you will be responsible for the support and coordination of the logistical aspects of clinical trial management, site management, data review & cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs. You\'ll act as a pivotal point of contact for the clinical trial team and assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. What You'll Be Doing Under moderate supervision, support and coordinate logistical aspects of clinical trials Assist in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids) Assist with preparation of training workshops, Investigator/Advisory Board meeting materials Assist with all phases of clinical trial activities (e.g. start-up, conduct, and close-out) Develop study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets) Maintain tracking spreadsheets/databases and provide routine reports/dashboards to study team members Request PO independently, may review invoices with oversight from Clinical Project Manager (CPM) Track essential documents and maintain/review the eTMF under the guidance of CPM Assist with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee Assist the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries Assist with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports) Assist with filing and management of the Electronic Trial Master File (eTMF) Distribute meeting agendas, prepare and distribute final meeting minutes including documentation of action items May assume a specialized administrative role (e.g. SOP Administrator) Travel up to 5% of the time is required What We're Looking For Bachelor\'s degree required; scientific discipline or related healthcare field is strongly preferred Minimum 1 year clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting) 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 PowerPoint 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 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 Why You Should Apply By joining REGENXBIO, you will have the opportunity to be part of a growing company and a dedicated team passionate about developing novel AAV gene therapy products. You\'ll have opportunities for professional development, exposure to challenging projects, and resources to help you grow personally and professionally. We offer a comprehensive rewards package including base salary, annual bonus potential, stock grants at all levels, health/dental/vision insurance, a 401(k) with match, and other benefits. #J-18808-Ljbffr REGENXBIO

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