Overview
This role provides legal advice and counsel to a national center for clinical trials, an institutional review board (IRB), the office of clinical research, the office of sponsored programs, and the clinical research function generally. The position involves guidance on regulations from the Department of Health and Human Services and the Food and Drug Administration, including oversight related to clinical research and IRB activities.
Responsibilities
- Provide legal counsel on clinical research and IRB-related matters.
- Manage negotiation processes for clinical trial agreements and other related agreements such as data use and collaboration agreements.
- Draft, review, and negotiate modifications to agreements to ensure compliance with organizational requirements and standards.
- Develop and maintain contract templates and playbooks to facilitate contract negotiations.
- Collaborate with industry sponsors, academic institutions, and other healthcare systems to facilitate agreements for collaborative research.
- Review grants and grant applications for legal issues and risks, working with internal stakeholders to clarify organizational obligations.
- Provide advice on investigatory matters related to clinical research and the IRB.
Requirements
- Juris Doctor (JD) degree.
- Licensed attorney authorized to practice law in any U.S. state.
- Minimum of 7 years of experience representing healthcare entities, working in contract research organizations, pharmaceutical companies, or a combination thereof.
- Demonstrated ability to act as counsel on a variety of healthcare legal matters, with a focus on clinical research and IRB issues.
- Experience performing legal research, drafting, and editing clinical research legal documents.
- Proficiency in drafting and reviewing clinical trial agreements, confidentiality agreements, data use agreements, and collaboration agreements.
- Strong organizational and project management skills to manage multiple legal transactions and issues simultaneously.
- Specialized knowledge of local, state, and federal laws and regulations related to clinical research.
- Ability to integrate digital tools and artificial intelligence in legal research, drafting, and communications.
- Experience handling confidential and sensitive matters involving healthcare providers, pharmaceutical companies, management, and regulatory agencies.
- Strong analytical skills to assess laws, regulations, case law, contracts, and risk management issues.
- Excellent verbal and written communication skills with the ability to collaborate effectively across all organizational levels.
- Ability to work within a complex corporate system environment.
Additional Information
- This is a remote position.
- Responsibilities and requirements may be modified to reasonably accommodate individuals with disabilities.
- This job description is not exhaustive and may include other duties as assigned by leadership.