Job Overview
Location
USA Remote
Job Type
Full-time
Category
HR & Recruiting
Date Posted
April 21, 2026
Full Job Description
đź“‹ Description
- • The Senior Specialist, Regulatory Operations at CareAccess Inc. plays a critical role in ensuring regulatory compliance for clinical trials across U.S. and Canadian sites, directly supporting the company’s mission to make health research accessible to underserved communities.
- • Day-to-day responsibilities include providing regulatory advice, managing IRB submissions, overseeing essential records, supporting site start-up and close-out activities, tracking timelines, preparing for sponsor monitoring visits, and ensuring compliance with FDA, OHRP, and GCP standards.
- • The role operates within the Global Regulatory Operations Team, part of the Global Expansion and Study Operations department, collaborating with Clinical Operations, Quality, and cross-functional teams to uphold regulatory excellence in a fast-paced, remote-first environment.
- • The incumbent will deepen expertise in U.S. regulatory frameworks, lead process improvements, mentor site staff on regulatory intelligence, and contribute to the development of SOPs and best practices that enhance study readiness and compliance across the organization.
🎯 Requirements
- • Bachelor’s degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
- • Minimum of 4 years of experience in operational regulatory affairs within research sites, CROs, or pharmaceutical industry, with a focus on U.S. regulatory requirements.
- • Demonstrated success in managing IRB and regulatory submissions, including FDA interactions, and strong understanding of U.S. regulations and ICH GCP guidelines as they relate to site operations.
- • Experience with electronic Investigator Site File systems (e.g., Florence, CRIO) and strong computer skills in MS Word, Excel, and clinical trials databases.
- • Ability to communicate effectively, manage competing priorities, work independently in a fast-paced environment, and maintain a client-service mentality with strong attention to detail and problem-solving skills.
🏖️ Benefits
- • 100% employer-paid medical, dental, and vision insurance plan options for employees.
- • Paid Time Off (PTO) and company-paid holidays, plus Health Savings Account (HSA) and Flexible Spending Account (FSA) availability.
- • Bi-weekly HSA employer contributions, company-paid short- and long-term disability, and 401(k) retirement plan with company match.
- • Remote work within the United States with less than 10% travel required.
- • Commitment to diversity, inclusion, and equal opportunity employment, with accommodations available upon request.
Skills & Technologies
About CareAccess Inc.
CareAccess Inc. is a healthcare technology company focused on improving patient access to care. They provide a platform that connects patients with healthcare providers, streamlining appointment scheduling, prescription management, and communication. Their solutions aim to reduce administrative burdens for providers and enhance the patient experience by offering convenient and efficient access to medical services. CareAccess leverages technology to bridge gaps in the healthcare system, making it easier for individuals to receive the care they need when they need it. The company is dedicated to innovating healthcare delivery through digital solutions.
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