Associate General Counsel Senior, Clinical Research
Advocate Aurora Health
Atrium Health Wake Forest Baptist - Medical Center Blvd, Winston Salem, NC
Full-Time
$99
RemoteSenior
Department:
Status:
Benefits Eligible:
Hours Per Week:
Schedule Details/Additional Information:
Hybrid remote
Pay Range
$99.75 - $159.60Major Responsibilities:
Provides legal advice and counsel toAdvocateHealth’sNational Center for Clinical Trials,the Advocate Health Wake Forest University School of MedicineInstitutional 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 ProtectionProgram) related to clinical research and IRB activities.
Manages the negotiation process for clinical trial agreements and certain other agreements(includingdata useandcollaborationagreements)that relate toAdvocateHealth'sclinicalresearch activities.
Drafts and reviews agreements and negotiates modifications to ensure compliance withAdvocate Healthrequirements and standards.
Develops andmaintainscontract templates and playbooks tofacilitatecontract negotiations.
Interacts with industry sponsors, academic institutions,and other health care systems as necessary tofacilitateagreements 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 ofAdvocateHealth’s obligations under those grants.
Provides advice and counsel on investigatory matters related to clinical research and the IRB.
Licensure, Registration, and/or Certification Required:
Attorney licensed to practice lawin any state in the United States.
Education Required:
Juris Doctor degree.
Experience Required:
Requires a minimum of7years’experiencerepresenting health care entities,working in a contract research organizationor pharmaceutical company or a combination ofany of theseand demonstrated ability to act as counsel on a variety of health care legal matters, with a focus on clinical research and IRB issues.
Knowledge, Skills & Abilities Required:
Experiences in performing legal research,draftingand editing variousclinical researchlegal documents andadvising an organization toensureappropriate legalprocesses are followed.
Excellent writing skills withdemonstratedproficiencyin drafting and reviewingclinical 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 andtimelymanage multiple, simultaneous legal transactions and issues.
Specialized knowledge in local,stateand federal laws and regulationsrelating to clinical research.
Ability to integrate digital tools and artificial intelligence in legal research, reasoning,draftingand communications to enhance the quality,speedand context of legal services.
Knowledge,skillsand experience inassistingwith confidential and sensitive matters involving health care providers,pharmaceutical companies,managementand regulatory agencies.
Skills in analyzing laws, regulations, case law, standards, governing documents, contracts, risk management issues and matters toassistin 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.
DISCLAIMER
All responsibilities and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This job description in no way states or implies that these are the only responsibilities to be performed by an employee occupying this job or position. Employees must follow any other job-related instructions and perform any other job-related duties requested by their leaders.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
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
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.