Job description
The Opportunity:
REGENXBIO is an exceptional place where some of the best of brightest people have the opportunity to collaborate, touch amazing science, and contribute toward extraordinary plans. As a Contract Clinical Systems Specialist, you will be responsible for clinical system maintenance and inspection readiness activities related to the Trial Master File (TMF) and Clinical Trial Management System (CTMS). You’ll also perform regular inspection readiness activities (including but not limited to generating regular compliance reports, performing system inventories and document reviews, etc.) and will work with clinical system users/owners to manage issues to completion in line with REGENBXIO standard procedures and ICH/GCP. This is a 6-month contract position with the potential to convert to permanent.
What you’ll be doing:
- Working cross-functionally to support system setup and customization as required.
- Performing eTMF inventory and document reviews per applicable study specific plans and procedures.
- Performing regular system quality checks and communicate compliance gaps to clinical trial team members, medical organization leadership, and any/all applicable stakeholders as needed.
- Working with Clinical System owners to manage inspection readiness issues to completion.
- Monitoring eCTMS completeness and accuracy and provide compliance status update to system managers/owners as needed.
- Supporting system data/document entry, including oversight of eTMF/eCTMS system directories (e.g. reference data repositories).
- Monitoring system access and process user access requests.
- Participating in system related process improvement initiatives and standard document updates.
What we’re looking for:
- Bachelor’s degree with an emphasis on Life Sciences preferred.
- At least 5 year clinical research experience (or equivalent) handling/managing clinical system information (e.g. TMF documentation, eCTMS information, etc.)
- Must have working knowledge of ICH/GCP principals and demonstrate a working knowledge of clinical trial execution.
- Must have experience with clinical trial IT systems such as electronic Trial Master File and/or electronic CTMS.
- Demonstrates familiarity with industry standards
- Ability to work in a dynamic, fast paced, team environment
$0 - $1 a year
