Senior Specialist, Regulatory Operations

About this role

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.

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

The Senior Specialist, Regulatory Operations will oversee, support, 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 an excellent understanding of U.S. regulatory requirements and experience managing regulatory interactions and activities related to clinical research site operations.

How You'll Make An Impact

• Provide regulatory advice, lead, execute and deliver regulatory project work

• Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.

• 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.

• 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.

• Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements 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.

• Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements.

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

• Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents.

• Provides guidance and support to site staff with regards to regulatory intelligence and country requirements, including identifying and conducting training.

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

• Monitor and interpret changes in U.S. regulatory policies and guidelines, advising internal stakeholder on potential impacts.

• Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies.

• Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.

• Support the development, review, and maintenance of departmental Standard Operating Procedures (SOPs), work instructions, and forms

• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

The Expertise Required

• Ability to communicate and work effectively with a diverse team of professionals

• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors

• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals

• Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel

• Experience in electronics Investigator Site Files systems like (Florence, CRIO)

• Ability to balance tasks with competing priorities

• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done

• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure

• High level of self-motivatio

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