Senior Regulatory Specialist

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 

The Senior Regulatory Specialist will oversee all details of regulatory for assigned trials for both the traditional and decentralized site models and is responsible for ensuring compliance with regulations and supporting start up activities for all sites and studies. 

• Develop and execute regulatory strategies to obtain and maintain regulatory approvals for Care Access projects
• Lead communications and serve as main contact with regulatory bodies
• Develop, review, and submit high-quality and timely regulatory agency submission materials, including but not limited to protocols, ICFs and marketing materials
• Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies 
• Collaborate closely with cross functional teams, including, but not limited to senior leadership, patient marketing and study operations 
• Track essential documents and timelines
• Handling submissions to the IRB, management of essential regulatory documents 
• Maintain centralized document storage 
• Ensure quality is maintained in all investigator site files for assigned studies
• Support sites through their evaluation and begin start-up activities upon selection
• Support the site through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
• Support audits and monitoring visits to ensure regulatory compliance
• Oversee activities throughout the duration of the study; supporting clinical operations teams as required
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Actively work towards KPIs to help ensure departmental success
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Work with department head on new initiatives and projects to help grow department  
• Display high level of integrity and professionalism 
• 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
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• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. 

• Ability to communicate and work effectively with a diverse team of professionals
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments
• 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
• Ability to balance tasks with competing priorities
• Critical thinker and problem solver
• 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 

• Bachelor’s Degree or work experience may substitute for required education
• A minimum of 5 year of experience in regulatory; central regulatory experience required
• Strong knowledge of regulations
• CCRP preferred

• 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. 

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.