Job Description
The Regulatory Specialist will oversee all details of regulatory for assigned trials for both the traditional and decentralized site models. This role ensures compliance with regulations and supports start-up activities for all sites and studies.
Key responsibilities include tracking essential documents and timelines, handling submissions to the IRB, managing essential regulatory documents, and maintaining centralized document storage. The specialist will also ensure quality in all investigator site files, support sites through various stages from evaluation to study closeout, and actively work towards KPIs to ensure departmental success.
This remote position requires less than 10% travel and offers benefits such as paid time off, comprehensive insurance coverage, and a 401k retirement plan.
About Care Access
Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.