Senior Regulatory Specialist, Care Access
More information about location
Decentralized clinical research & trial services
Open for applications
Decentralized clinical research & trial services
501-1000 employees
Open for applications
More information about location
501-1000 employees
Company mission
Care Access' mission is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient.
Role
Who you are
- 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
What the job involves
- 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
Our take
Through a network of distributed clinical research sites, on-demand popup sites, mobile infrastructure, and traveling clinical professionals, Care Access allows for decentralized clinical trials especially in underserved communities.
Decentralized and virtually managed trials exploded in popularity during the height of the Covid-19 pandemic, and due in part to how they can bring access to underrepresented demographics, they look set to stay.
Founded in 2016, Care Access’ work predates the pandemic, putting the company in a very strong position to lead the way as this kind of clinical trial becomes more mainstream.
Indeed, the company recently acquired IBPClin, a clinical trial center in Brazil, highlighting its intention to grow its model in South America as well as at home in the US.
Steph
Company Specialist at Welcome to the Jungle
Insights
Few candidates hear
back within 2 weeks
Company
Company benefits
- PTO/Vacation days, sick days, Holidays
- 100% paid Medical, Dental, and Vision Insurance. 75% for dependents
- HSA plan Short-term disability, long-term disability, Life Insurance
- Continued Education Allowance
- Culture of growth and equality
- 401K plan and matching contribution
Company HQ
Downtown Crossing, Boston, MA
Articles
Leadership
Ahmad Namvargolian
(CEO)Was a Research Scientist at the Lawrence Berkeley National Laboratory in California. Holds a Master's in Public Policy from the University of Chicago.
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