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 Senior Clinical Trial Associate, you will be responsible for coordinating the logistical aspects of clinical trials and electronic Trial Master File (eTMF) support according to Good Clinical Practice (GCP) and relevant SOP’s. 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
- 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 CPM
- Tracks essential documents and maintains/reviews the eTMF under the guidance of a CRA 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
- Participates in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned Clinical Research Associate (CRA) or designee
- Assists the CRA with the flow of data, including but not limited to facilitating resolution of queries under guidance of CRA or Clinical Project Manager (CPM)
- 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)
- Provides agendas, minutes, and action items for project team meetings
- May assume a specialized administrative role (e.g. SOP Administrator)
- 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:
- Bachelor's degree required preferably in a scientific discipline or related healthcare field
- 1-2 years’ applicable experience preferred, in a scientific or medical field.
- Must have knowledge in reference to GCP/ICH and SOPs
- Experience working with eTMF; Veeva experience preferred
- Working knowledge and understanding of clinical protocols, and all other associated study related documents
- Familiar with basic concepts of clinical research
- Advanced knowledge of Word, Excel and Power Point
- 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 collaboration skills
- Clear and concise verbal and written communication skills
- Attention to detail required
- Ability to handle 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! The estimated compensation range for this role is $76,000 to $100,000 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. Apply for this job
