Negotiates and finalizes (in collaboration with Loyola University Medical Center (“LUMC”) the terms and conditions of industry and government- funded clinical trial, research service, data use, non-disclosure , material transfer and other related agreements, in a timely manner, designed to protect Loyola University of Chicago (“LUC”) and the Principal Investigator (“Pl”), with focus on 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) confidentiality; f) warranty; g) infringement, at a minimum.
- Reviews, interprets, analyzes, drafts and negotiates federal and industry research, clinical trial and related agreements within LUC and LUMC established legal, financial and risk management guidelines and templates;
- Effectively and efficiently redlines all agreements, including but not limited to, clinical trial agreements, master agreements, research service agreements, data use agreements, non-disclosure agreements and material transfer agreements;
- Fosters and maintains mutually beneficial relationships with corporate biomedical and healthcare sponsors; providing high quality and timely service to Principle Investigators (PI), while maintaining a balance between LUC, LUMC and industry interests for the public good;
- Negotiates any extensions of existing contracts or agreements;
- Performs other duties as required.
Bachelor degree required. At least (2) 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.
Contract management, paralegal, or other comparable experience preferred.
In addition to meeting the minimum qualifications for the position, the following are preferred qualifications for the candidate:
- A skilled negotiator with a track record of success.
- 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.
- Accomplished at developing and maintaining business relationships with internal and external stakeholders
- Ability to handle multiple tasks simultaneously in a high-pressure, time-sensitive environment.
Loyola University Chicago
Authorized to work in the US