Associate General Counsel Clinical Trials opportunity with UCHealth, located in Aurora, CO.
Job Summary and Responsibilities
· A n alyzes, m a n a g es, a n d advis e s o n all clinical trial-related legal matters; including advising Institutional Review Boards (IRB).
· I n v es t i g at e s, r e searches, and ev al u at e s issues t o d e t er m i n e the o r g a n i z ati o n' s ri gh ts a n d r e sponsi b ilities.
· 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.
At UCHealth, we do things differently
We believe in something different: a focus on the individuality of every person. In big ways and small, we exist to improve the extraordinary lives of all those we serve. As Colorado's largest and most innovative health care system, we as a team deliver on the commitment to provide the best possible experience for our patients and their families. We foster a true human connection and give people the freedom to live extraordinary lives. A career at UCHealth is more than a job, it's a passion.
Going beyond quality requires the perfect balance of talent, integrity, drive and intellectual curiosity. We are looking for individuals who recognize, like us, that the world of medicine is ever-changing and are motivated to do what is right, not what is easy. We support creativity and curiosity so that each of us can find the extraordinary qualities within ourselves. At UCHealth, we'll do everything in our power to make sure you grow and have a meaningful career. There's no limits to your potential here.
Be Extraordinary. Join Us Today!
UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an affirmative action/equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, creed, color, religion, gender, national origin or ancestry, age, mental or physical disability, sexual orientation, gender identity, transgender status, genetic information or veteran status. UCHealth does not discriminate against any "qualified applicant with a disability" as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization.
With award-winning hospitals and facilities serving the entire Front Range, University of Colorado Health is the state’s largest and most innovative health system. By integrating the strengths of academic medicine with the finest community health care, we’re able to push the boundaries of medicine and offer our employees endless career opportunities. Here, there are no limits, except those you place on yourself. Everyone is united by their passion for discovery and their commitment to improving patients’ lives.