The Specialist, Regulatory Operations oversees regulatory activities for clinical trials, ensuring compliance and supporting site operations. Responsibilities include managing IRB submissions, regulatory documentation, and collaborating with cross-functional teams.
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.
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 ImpactThe Expertise RequiredHow We Work Together
- 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.
- 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 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 for regulatory inspections and sponsor audits.
- Milestones: Tracks and updates the study team accordingly
- Other Responsibilities
- Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.
- Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.
- 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.
- Ability to communicate and work effectively with a diverse team of professionals
- Communication Skills: Good 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
- Good computer skills with demonstrated abilities using clinical trials database, MS word and excel
- Experience in electronics Investigator Site Files systems like (Florence, CRIO)
- 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 submissions
- Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges
- Ability to handle multiple tasks in a fast-paced and constantly changing environment.
Certifications/Licenses, Education, and Experience:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience
- Minimum of 2 years of experience in operational regulatory affairs within theresearch site (preferable), or -CRO/pharmaceutical industry.
- Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
- Good 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.
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
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]
Top Skills
Clinical Trials Database
Crio
Florence
Excel
Ms Word
Care Access Boston, Massachusetts, USA Office
33 Arch Street, 17th Floor, Boston, MA, United States, 02110
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