Specialist, Regulatory Operations

Job Description

Job Description

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 into 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.

To learn more about Care Access, visit www.CareAccess.com.

How This Role Makes a Difference

Care Access is seeking a skilled and experienced Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department.

The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required.

You will have a good understanding of U.S. regulatory requirements and experience supporting regulatory activities for clinical research sites.

How You'll Make An Impact

Study-specific regulatory operations :

Act as main regulatory operations contact for assigned studies

• Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, -OHRP and global regulatory standards.
• Coordinates preparation and review of key site essential records.
• Assist in preparing for sponsor monitoring visits and follow up requirements, ensuring compliance and readiness for assigned studies.
• Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• 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 life cycle; 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.

Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials.

Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents for regulatory inspections and sponsor audits.

Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.

The Expertise Required

Certifications / Licenses, Education, and Experience :

How We Work Together

Benefits & Perks

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to : TalentAcquisition@careaccess.com