Job Description
Care Access is seeking a skilled and experienced Senior Specialist, Regulatory Operations to join our dynamic Global Regulatory Affairs Team, part of the Global Expansion and Study Operations department. You will provide regulatory advice, lead, execute and deliver regulatory project work, and support regulatory compliance activities for Canadian and USA clinical research sites, ensuring to adherence to Health Canada, FDA and global regulatory standards. You will also assist in preparing for sponsor monitoring visits and follow up requirements; develop and implement regulatory strategies to support sites activities; provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices; track essential documents and timelines; support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout; actively work towards KPIs to help ensure departmental success; support creation and maintenance of study Delegation of Authority (DOA) logs.
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.