Associate General Counsel Senior, Clinical Research
About The Position
Provides legal advice and counsel to Advocate Health’s National Center for Clinical Trials, the Advocate Health Wake Forest University School of Medicine Institutional Review Board, the Office of Clinical Research, the Office of Sponsored Programs, and the clinical research function generally, including but not limited to legal counsel and guidance on regulations promulgated by the Department of Health and Human Services and the Food and Drug Administration (including the Office of Research Integrity and the Human Research Protection Program) related to clinical research and IRB activities. Manages the negotiation process for clinical trial agreements and certain other agreements (including data use and collaboration agreements) that relate to Advocate Health's clinical research activities. Drafts and reviews agreements and negotiates modifications to ensure compliance with Advocate Health requirements and standards. Develops and maintains contract templates and playbooks to facilitate contract negotiations. Interacts with industry sponsors, academic institutions, and other health care systems as necessary to facilitate agreements for the purpose of collaborative research work. Reviews grants and grant applications for legal issues and risks and works with internal stakeholders to promote a clear understanding of Advocate Health’s obligations under those grants. Provides advice and counsel on investigatory matters related to clinical research and the IRB.
Requirements
- Attorney licensed to practice law in any state in the United States.
- Juris Doctor degree.
- Requires a minimum of 7 years’ experience representing health care entities, working in a contract research organization or pharmaceutical company or a combination of any of these and demonstrated ability to act as counsel on a variety of health care legal matters, with a focus on clinical research and IRB issues.
- Experiences in performing legal research, drafting and editing various clinical research legal documents and advising an organization to ensure appropriate legal processes are followed.
- Excellent writing skills with demonstrated proficiency in drafting and reviewing clinical trial agreements, confidentiality agreements, data use agreements, and collaboration agreements.
- Skills in analyzing law and providing effective recommendations.
- Strong organizational and project management skills to effectively and timely manage multiple, simultaneous legal transactions and issues.
- Specialized knowledge in local, state and federal laws and regulations relating to clinical research.
- Ability to integrate digital tools and artificial intelligence in legal research, reasoning, drafting and communications to enhance the quality, speed and context of legal services.
- Knowledge, skills and experience in assisting with confidential and sensitive matters involving health care providers, pharmaceutical companies, management and regulatory agencies.
- Skills in analyzing laws, regulations, case law, standards, governing documents, contracts, risk management issues and matters to assist in protecting the organization from legal risk.
- Excellent verbal and written communication skills.
- Ability to communicate and collaborate effectively with all levels of employees, management, executives, and other organizations and to address difficult and controversial issues, organizational policies and procedures, and federal and state regulations.
- Ability to work and function in a complex corporate system environment.
Responsibilities
- Provides legal advice and counsel to Advocate Health’s National Center for Clinical Trials, the Advocate Health Wake Forest University School of Medicine Institutional Review Board, the Office of Clinical Research, the Office of Sponsored Programs, and the clinical research function generally, including but not limited to legal counsel and guidance on regulations promulgated by the Department of Health and Human Services and the Food and Drug Administration (including the Office of Research Integrity and the Human Research Protection Program) related to clinical research and IRB activities.
- Manages the negotiation process for clinical trial agreements and certain other agreements (including data use and collaboration agreements) that relate to Advocate Health's clinical research activities.
- Drafts and reviews agreements and negotiates modifications to ensure compliance with Advocate Health requirements and standards.
- Develops and maintains contract templates and playbooks to facilitate contract negotiations.
- Interacts with industry sponsors, academic institutions, and other health care systems as necessary to facilitate agreements for the purpose of collaborative research work.
- Reviews grants and grant applications for legal issues and risks and works with internal stakeholders to promote a clear understanding of Advocate Health’s obligations under those grants.
- Provides advice and counsel on investigatory matters related to clinical research and the IRB.
Benefits
- Comprehensive suite of Total Rewards: benefits and well-being programs
- Competitive compensation
- Generous retirement offerings
- Programs that invest in your career development
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
