In-House CRA / Clinical Trial Associate

The opportunity:

As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as a pivotal point of contact for the clinical trial team. Under general supervision, you will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Although prior CRA experience is not essential, a working knowledge of the clinical trial process and associated regulations, responsibilities, and roles are required.

What you’ll be doing:

• Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
• Assists with preparation of training workshops, Investigator/Advisory Board meeting materials
• Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
• Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
• Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members
• Requests PO independently, may review invoices with oversight from Clinical Project Manager (CPM)
• Tracks essential documents and maintains/reviews the eTMF under the guidance of CPM.
• Assists 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
• Assists the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries
• Assists 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)
• Assists with filing and management of the Electronic Trial Master File (eTMF)
• Distributes meeting’s agenda, prepare and distributes 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:

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

•  A Bachelor’s degree (BA or BS) with an emphasis on scientific discipline or related healthcare field preferred, however, the combination of experience working in clinical research field and training will be taken under consideration.
• 1-2 years applicable experience in a pharmaceutical, biotechnology, CRO and /or healthcare setting required
• 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 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
• Attention to detail and organizational skills required
• Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines

Why should you apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need.

We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

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.  

Qualifications