Live chat
UCHealth

Associate General Counsel - Clinical Trials

UCHealth - Aurora, CO

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.)




Requirements



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



 



·         5 years' experience in a healthcare setting.



 



·         State licensure as an attorney.



 



Apply here.



19 days 3 hours ago

UCHealth

apply

Associate General Counsel - Clinical Trials UCHealth - Aurora,CO,United States

   

Location: Aurora, CO