Title -Clinical Research Associate (In-House) -About the Organization -REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our NAV Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV Vectors to other leading biotechnology companies. -Req Number -CLI-18-00014 -Description -POSITION SUMMARY The Clinical Research Associate (CRA) is an in-house position, based in Rockville, Maryland. The CRA is responsible for supporting the Clinical Operations Team with activities involving the planning, initiation, and management of clinical trials, with a strong focus on enrollment, data quality, investigational site relationships, and adherence with SOPs, Good Clinical Practices (GCP/ICH) regulatory guidelines. Candidates must have the ability to prioritize multiple tasks, have strong computer skills and a foundational knowledge of clinical trial execution PRIMARY RESPONSIBILITIES -Create, implement, and maintain systems to track study metrics and general information relating to study execution including but not limited to minutes, essential regulatory documents, decision and action item logs. -May prepare trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, patient instruction guides, and Case Report Forms (CRFs) -Reviews site-specific study documents (site-specific ICF and study tools/worksheets), investigator contracts, and site payments -May track and present study metrics including CRO and other vendor activities -Tracks essential documents received, and maintains the eTMF system, and conduct periodic QC of the eTMF to ensure the health of the documents filed -Participates in team meetings and may lead small operational teams and/or participates in collaborative efforts (e.g. Standard Operating Procedure (SOP) development, operational task forces, etc.) -Assists clinical project manager in study management -Generate purchase orders, process vendor invoices and assist in tracking spend approved in the budget -Assist the organization of investigator meetings and advisory boards as necessary -Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments -May perform duties assigned to clinical project manager as a stretch role for growth opportunity with appropriate mentoring -Position Requirements -SKILLS, KNOWLEDGE AND ABILITIES REQUIRED -Bachelors degree required with an emphasis on Life Sciences preferred. -Two years clinical research experience (e.g. CRA, CTA, or equivalent) TECHNICAL SKILLS -Must have knowledge in reference to GCP/ICH and SOPs -Strong working knowledge and familiarity with all types of clinical site monitoring -Familiar with the basic concepts of clinical research and development and able to work effectively in a team environment -Developing level of professional expertise through familiarity with industry literature and participates in project team meetings -Ability to work in a dynamic, fast paced environment WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS Normal working conditions MANAGER/SUPERVISORY RESPONSIBILITIES None -Location -Rockville, Maryland -Exempt/Non-Exempt -Exempt -EOE Statement -We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. -Open Date -9/13/2018 -This position is currently accepting applications.