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.
This is a full time, temporary, position.
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-motivation and energy
- Ability to work independently in a fast-paced environment with supervision
- Must have a client service mentality
- Demonstrated success in managing IRB and regulatory submissions, including FDA interactions.
- Detail-oriented with strong problem-solving abilities and a proactive approach to regulatory challenges.
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
- Strong strategic planning, risk management, managing, monitoring and change management skills.
Certifications/Licenses, Education, and Experience
- Minimum Education:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
- Minimum Experience:
- Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements.
- Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
- Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
- Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.
How We Work Together
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: [email protected]
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
