Regulatory Study Start-Up Specialist

Care Access is building the future of healthcare, where many more life-changing therapies can reach those who need it most.

Care Access

Employee count: 201-500

United States only

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What We DoCare 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 AreWe 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 OverviewThe Regulatory Study Start-Up 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.What You'll Be Working OnDuties include but not limited to: ·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-inclusivePhysical and 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 BringKnowledge, Skills, and Abilities:·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 Certifications/Licenses, Education, and Experience:·Bachelor’s Degree or work experience may substitute for required education·A minimum of 3 year of experience in regulatory; prefer site level ·CCRP preferredBenefits (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 planDiversity & InclusionWe 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 bestphysicians 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 StatementCare 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.

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Full Time

Experience level

Mid-level

Location requirements

United States

Hiring timezones

United States +/- 0 hours

About Care Access

Learn more about Care Access and their company culture.

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Care Access is building the future of healthcare, where many more life-changing therapies can reach those who need it most. We are uniting standard patient care with cutting-edge treatments and research to uncover a world where medical breakthroughs don’t end in the lab but instead make it to patients quickly and transform lives. Through innovation and a unique technology-enabled service model, our team of expert scientists, engineers, entrepreneurs, physicians, nurses, and patient volunteers are paving the way towards this more caring and creative world. Along the way, we are caring for each other, accelerating medicine, and seeding a long-term impact for generations to come.

Our values are rooted in being genuine and authentic. We don't do things for show or because it’s trendy; what we say is meant and what we do is meaningful. We don't have internal politics and our teamwork is not an artificial construct; rather, it is a natural consequence of really smart, caring people working together. This translates into us valuing communication and dialogue: we care about what everyone has to say and we spend energy on being inclusive. We don't work in an environment where it's okay for someone to get crushed, and we take steps to prevent and avoid that. This creates the groundwork where everyone is encouraged to shine and where merit-based chances to excel are plentiful.

Tech stack

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JavaScript

HTML5

CSS 3

Facebook Ads

Salesforce

Google Analytics

Adobe Photoshop

Lever

HubSpot

Adobe Illustrator

LinkedIn Sales Navigator

4 more

Care Access employees can create an account to update this tech stack.

Employee benefits

Learn about the employee benefits and perks provided at Care Access.

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Paid vacation

PTO/Vacation days, sick days, holidays.

Life insurance

Short-term disability, long-term disability, life insurance.

Healthcare insurance

Medical, dental, and vision insurance for employees and dependents.

Learning and development budget

Learning and development budget per year stipend to grow your skills.

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About the job

Apply before

Aug 28, 2024

Posted on

Jun 29, 2024