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Job Details

Associate General Counsel - Clinical Trials

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5 yrs required

Aurora, CO

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Associate General Counsel Clinical Trials opportunity with UCHealth, located in Aurora, CO.  

Job Summary and Responsibilities

  • Analyzes, manages, and advises on all clinical trial-related legal matters; including advising Institutional Review Boards (IRB).


  • Investigates, researches, and evaluates issues to determine theorganization's rights and responsibilities.


  •  Evaluate and advise on FDA and Common Rule regulations, compliance requirements, informed consent forms supporting clinical research, pre-clinical research and development, and high-stakes matters presented in the context of FDA inspections of clinical investigations. 


  • Draft and negotiate non-disclosure agreements and clinical trial agreements between the UCHealth affiliated hospitals and pharma/biotech/academic systems, including but not limited to standard clinical trial agreements, master clinical trial agreements, and multi-site affiliations. 


  • Draft, revise, and advise UCHealth leadership IRB and Research Department on SOPs and guidelines. 


  • Advise UCHealth on research billing matters, with an emphasis on the Medicare Secondary Payer rule. 


  • Provide counsel on federal grants and awards where UCHealth affiliated hospitals are prime, sub, or are involved in other hub/spoke models. 


  • Serves as primary liaison to the School of Medicine for research-related matters.


  • Responsible for the corporate governance, secretarial responsibilities, and corporate and entity documents for all boards, including Foundation Boards (excluding governance and secretarial responsibilities for UCHealth.)


·         Juris Doctor (J.D.) from an accredited law school.


·         5 years' experience in a healthcare setting.


·         State licensure as an attorney.


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