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Loyola University Chicago
1032 W. Sheridan Rd.
Description- Within LUC established legal, financial and risk management guidelines and templates, reviews, interprets, analyzes, drafts and negotiates affiliation and other site agreements with over 500 different clinical sites for medical, exercise science, dietetic, health systems management and nursing student training and education.
- Negotiates and finalizes terms and conditions of research and clinical-trial agreements in a timely manner and in a manner designed to protect Loyola University of Chicago ("LUC"), the Principal Investigator ("PI") and Loyola University Medical Center ("LUMC") in the following major areas: a) patient and medical staff safety; b) intellectual property (IP) rights and ownership; c) liability (damages, injury and indemnification) and insurance; d) publication; e) warranty; f) infringement at a minimum.
- Within LUC and LUMC established legal, financial and risk management guidelines and templates, reviews, interprets, analyzes, drafts and negotiates industry research, clinical trial and associated types of agreements like confidentiality agreements, clinical trial agreements and material transfer agreements,
- Secures approval of LUC and LUMC legal, finance and risk management departments to finalize any contract terms outside of established guidelines and templates.
- Fosters and maintains mutually beneficial relationships with corporate biomedical and healthcare sponsors; providing high quality and timely service to principal investigators (PI), while maintaining a balance between LUC, LUMC and industry interests for the public good.
- Maintains systems that log, track and report the status of outstanding agreements to PI, Deans, Research Services and all interested constituents at LUC and LUMC.
- Negotiates any extensions of existing contracts or agreements.
- Maintains files for all agreements within LUC, research, sponsored program and contract administration policies and/or guidelines.
- Performs other duties as required.
RequirementsBachelors of Science is required. JD desired. Three to five (3-5) years of clinical trial agreement review and negotiation experience with at least two (2) years in an academic setting preferred, or equivalent combination of education and experience.
- Must be a skilled negotiator with a track record of success.
- Must have working knowledge of relevant laws, intellectual property, indemnity and other university-industry clinical trial provisions; required biotech and pharmaceutical laws and regulations including FDA, GCP, HIPAA and ICH.
- Ability to identify and resolve problems in a timely manner.
- Ability to write clearly and informatively.
- Ability to meet challenges with resourcefulness.
- Ability to develop innovative approaches and ideas.
- Must exhibit sound and accurate judgment.
- Ability to support and explain reasoning for decisions.
- Ability to commit to long hours of work when necessary to reach goals.
- Ability to include appropriate people in decision-making process.
- Ability to prioritize and plan work activities.
- Ability to utilize time efficiently; and complete work on time.