Clinical Research Agreement Specialist

5 days ago

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Care Access

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A new vision for healthcare. Where clinical research is a patient care option.

rare diseases • pulmonology • oncology • decentralized • decentralized trials

201 - 500

Description

• 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. • 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. • 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.

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. • 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. • 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.

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, and life Insurance. • Culture of growth and equality • 401k retirement plan