Clinical Research Agreement 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.  

What You'll Be Working On 

Duties include but not limited to: 

·        Collect and respond to official Award Letters to establish lines of communication and request pertinent documents and information. 

·        Draft, structure, review, and negotiate clinical trial Agreements (CTAs) and other related contracts with customers and vendors. 

·        Serve as a key point of contact between Care Access and third parties to ensure timely review, approval, and execution of clinical agreements, including any amendments or variations thereof.  

·        Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up. 

·        Liaise with internal stakeholders and departments to confirm any requested content changes to the CTAs are agreeable. 

·        Regularly maintain and update contract status on the tracker. 

·        Upload documents, including protocols and manuals, to the appropriate location. 

·        Develop and maintain excellent working relationships with clients to understand and meet their needs as agreeable to the company. 

·        Develop and maintain excellent working relationships with clients to understand and meet their needs as agreeable to the company. 

·        Identify opportunities to improve business processes and contracting efficiencies. 

·        Help ensure compliance and conformity with applicable federal and state laws governing the organization. 

·        Comprehend standard contract language and structure.  

·        Recognize organizational risks, limitations, or concerning language and understand proper escalation points when language modifications are proposed by external parties.Comfort and skill articulating and discussing contracting issues and working with legal partners and other departments to resolve them. 

·        Work with Research Budget Analysts to understand and assist in negotiating study budgets and other financial terms. 

·        Complete and provide any supplemental forms as requested by Sponsors/CROs. 

Physical 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 Bring 

Role Requirements: 

·        Deep knowledge of legal terminology, essential contract terms, boilerplate, contextual impacts, risks, and key considerations. 

·        Familiarity with medical terminology- ability to read and understand a protocol. 

·        Solid time management and organizational skills. 

·        Experience reviewing and redlining contracts with excellent attention to detail. 

·        Robust knowledge of legal contracting processes and standards. 

·        Outstanding communication and interpersonal abilities. 

·        An analytical, solutions-driven mindset. 

Knowledge, Skills, and Abilities: 

·        Working knowledge of medical and research terminology. Working knowledge of applicable federal regulations and GCP. 

·        Ability to communicate and work effectively with a diverse team of professionals. 

·        Strong organizational skills: Able to plan, prioritize, support, and follow through communication Skills: -Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors. 

·        Team Collaboration Skills: Works effectively and collaboratively with other team members to accomplish mutual goals.  

·        Bring a positive and supportive attitude to achieving these goals. 

·        Ability to balance tasks and multiple competing priorities. 

·        Capable of professionally managing confidential information. 

·        Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done. 

·        Friendly, outgoing personality; maintain a positive attitude under pressure. 

·        Professional with a high level of self-motivation and energy. 

·        Ability to work independently in a fast-paced environment with minimal supervision and adaptability. 

·        Proficient MS Office and general business skills. 

·        Must have a client-service mentality. 

Certifications/Licenses, Education, and Experience: 

·        Bachelor’s degree in law, paralegal studies, business administration, or a related field, or the equivalent relevant working experience. 

·        A minimum of 3 years as a contract specialist, legal review and negotiation professional, or another legal-related function. 

·        Clinical research experience is a plus. 

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 

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 currently unable to sponsor work. 

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.