Job Description

Clinical Research Associate

Rockville, Maryland

Medical Organization - Clinical Operations / Full Time / On-site

Who we are

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 provides 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
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

What we're looking for

• Bachelors degree required; scientific discipline or related healthcare field is strongly preferred
• Minimum 1 years 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 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

$0 - $1 a year

Why You Should Apply

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $90,000 to $120,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.

In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.

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