Specialist, Regulatory Operations
What We Do:
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are:
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview:
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.
What You'll Be Working On
Duties include but are not limited to:
Primary Duties and Essential Functions
- 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/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 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.
Scope of Role
Autonomy of Role: Work is performed under general supervision
Direct Reports: No
Number of Direct Reports (if applicable): N/A
Role(s) Managing: N/A
Physical Requirements
This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment.
Travel Requirements
This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills, and Abilities:
- 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, 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.
Benefits (US Full-Time Employees Only):
- PTO/vacation days, sick days, holidays.
- 100% paid medical, dental, and vision Insurance.
- 75% for dependents.
- HSA plan Short-term disability, long-term disability, and life Insurance.
- Culture of growth and equality 401k retirement plan
Diversity & Inclusion:
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Originally posted on Himalayas
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