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DIRECTOR HSD CONTRACT ADMIN

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Loyola University Chicago is an Equal Opportunity / Affirmative Action Employer.

Position Details 

Position Details

Job Title DIRECTOR HSD CONTRACT ADMIN
Position Number 8150448
Job Category University Staff
Job Type Full-Time
FLSA Status Exempt
Campus Maywood-Health Sciences Division
Department Name OFFICE OF RESEARCH SERVICES
Location Code RESEARCH PROGRAM (06120A)
Is this split and/or fully grant funded? No
Duties and Responsibilities

1. Provides leadership to create and define legal, financial and risk management guidelines and templates, reviews, interprets, analyzes, drafts and negotiates other site agreements with over 500 different clinical sites for medical, exercise science, dietetic, health systems management and nursing student training and education.
2. Oversees the negotiations 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”), and the Principal Investigator (“PI”) 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.
3. Responsible for maintaining and fostering open and transparent lines of communication within LUMC and LUC legal departments and when needed LUC insurance department.
4. Responsibly for securing approval of LUC and LUMC legal, finance and risk management departments to finalize any contract terms outside of established guidelines and templates.
5. 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.
6. 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.
7. Oversees the negotiations of any extensions of existing contracts or agreements.
8. Responsible for creating and maintaining appropriate policies within HSD Contract Administration.
9. Develop and maintain a web page describing the services provided by HSD Contract Administration.
10. Is responsible to ensure files are maintained for all industry clinical trial, material transfer and non-disclosure agreements within LUC research.
11. Oversees the development, maintenance and training for the Contract Administration module within the research portal.
12. Recruits, hires, supervises, evaluates all staff and provides ongoing professional development and training as needed.
13. Develops, reviews, and manages strategic plans, assessment goals and objectives consistent with the HSD overall plan.
14. Performs other duties as required.

Minimum Education and/or Work Experience

Bachelors of Science/Arts is required. JD desired. Five to seven (5-7) years of clinical trial agreement review and negotiation experience with at least four (4) years in an academic setting preferred, or equivalent combination of education and experience. A minimum of 3 ? 5 years of managerial experience.

Qualifications

- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Must be a skilled negotiator with a track record of success.
- Must 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.

Certificates/Credentials/Licenses

N/A

Computer Skills

Basic Computer Skills

Supervisory Responsibilities Yes
Required operation of university owned vehicles No
Does this position require direct animal or patient contact? No
Physical Demands None
Working Conditions None
Open Date 12/07/2017
Close Date
Special Instructions to Applicants
Quick Link for Posting http://www.careers.luc.edu/postings/6452

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. Do you have a Bachelors of Science or Arts?
    • Yes
    • No
  2. Do you have a JD?
    • Yes
    • No
  3. Do you have at least five years of clinical trial agreement review/negotiation experience with at least four years in an academic setting (or equivalent combination of education and experience)?
    • Yes
    • No
  4. Do you have at least 3 years of managerial experience?
    • Yes
    • No

Applicant Documents

Required Documents
  1. Resume
  2. Cover Letter/Letter of Application
Optional Documents
  1. Other Document