About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

com . How This Role Makes a Difference Care Access is seeking a skilled and experienced Senior Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department. S.

They may also support regulatory activities for Canadian sites as needed. S. S.

sites when required. S.

Requirements

and experience managing regulatory interactions and activities related to clinical research site operations. This is a full time, temporary, position. S.

clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.

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. Coordinates preparation and review of key site essential records. Track essential records 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 Supports creation and maintenance of study Delegation of Authority (DOA) logs Support regulatory activities throughout the duration of the study lifecycle; collaborating with clinical operations teams to ensure regulatory compliance Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study/ies. Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials. S.

and site feedback. Liaise and follow up directly with Sponsor. Ensures accurate compilation, management and tracking of submissions.

Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness for regulatory inspections and sponsor audits. Milestones: Tracks and updates the study team accordingly.

. Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory

and internal processes.