Clinical Trials Officer
The University of Chicago

Job Info

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Department

Provost URA: Clinical Trials Contracting

About the Department

University Research Administration (URA) has the responsibility to review and provide institutional endorsement for all proposals to federal and other external sponsors (excluding gifts), assuring compliance with University policies and sponsor terms and conditions. URA is the institutional authority for the negotiation and acceptance of financial support or other contractually-binding obligations in the form of a contract, grant, or agreement, including material transfer agreements and clinical trials.

Job Summary

The Clinical Trials Officer is a member of the Clinical Trials Team on the Research Contract Group at University Research Administration. The Research Contract Group plays a key role in a team-based approach to faculty-centric development and execution of sponsored research, collaboration, and related agreements. The group is organized into teams that support Clinical Trials, Industry Collaboration and Research Related Grants and Contracts. This position will focus on Clinical Trial Agreements including, but not limited to, IIAs, Clinical Subsite Agreements and Non-disclosure Agreements.

This position uses best practices and knowledge of activities to support the functional areas of University Research Administration. Requires in-depth knowledge and experience. Uses best practices and knowledge of internal or external University issues to improve products or services. Solves complex problems; takes a new perspective using existing solutions. Acts as a resource for colleagues with less experience.

Working closely with the Senior Clinical Trial Officer and Director, Research Contracting, this role will be an integral part of advancing faculty and Institute research initiatives in the Clinical Trial and Clinical Research space working closely with the Office of Clinical Research and University leadership.

Responsibilities

• Advanced knowledge of contracting and related processes.
  
• Demonstrated understanding of university research environment and policies.
  
• Drafts, negotiates, and comments upon complex clinical trial agreements, confidentiality agreements, and other contracts that may support clinical trial activities.
  
• Consults with initiative team members, faculty/researchers, and outside partners as needed on explanation of, and compliance with, University policies and practices as they relate to contract terms and conditions.
  
• Acting as part of the Contracts Team, independently manages various agreement types from initiation to completion/execution in a timely, efficient, and thorough manner.
  
• Communicates clearly and consistently with stakeholders during the negotiation process.
  
• Maintains knowledge of current trends and developments in the field by attending professional development training, workshops, seminars and conferences and by reading professional literature in the related technical field.
  
• Has delegated authorization to sign agreements on behalf of the University under delegations authorized by the Associate Vice President for Research Administration.
  
• Applies advanced knowledge of contracting and related processes for all agreements/portfolio assigned to this position.
  
• Management/contract negotiation for all the units assigned to the position.
  
• The individual is a member of a Team and must contribute to the team effort, as needed. This might involve assisting colleagues to ensure timely campus service to departments, units, and sponsors, as needed and to perform backup duties during staff vacations or sick leaves.
  
• Interacts with individuals at companies and institutions regarding all agreement/contract types; faculty and administrative staff at the University; and on occasion with staff of the federal government, non-federal sponsors and other organizations.
  
• With moderate guidance, helps to obtain sponsor approvals for major changes to project work scope, etc. Transmits proposals and manages gathers and submits closeout documentation, and maintains records. Ensures completeness and accuracy and coordinates any internal controls prior to the submission of documents to awarding agency.
  
• Through interaction with a variety of federal and non-federal funding agencies, faculty, and staff, provides professional assistance with the administration and coordination of proposals and awards in research and training.
  
• Provides faculty and administrators with application preparation, analyzing possible solutions to problems that arise using standard procedures. Reviews, interprets, and negotiates contract and grant terms to determine compliance and/or conflict with federal regulations and procedures.
  
• Performs other related work as needed.
  

Minimum Qualifications

Education:
Minimum requirements include a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
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Certifications:

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Preferred Qualifications

Education:

• Law degree strongly preferred.
  

Experience:

• Paralegal or legal experience a plus.
  
• At least three years experience working in a university contracts-management environment, law firm, or in-house legal department or at least seven years of relevant experience drafting complex research or commercial agreements.
  
• Demonstrated experience in the management and/or negotiation of complex contracts.
  
• Proven ability to work effectively in support of business development and/or research administration and healthcare professionals.
  

Technical Skills or Knowledge:

• Familiarity with intellectual property concepts and federal laws and regulations as well as NIH guidelines pertaining to Clinical Research.
  
• Knowledge of academic research principles and research integrity policy (Conflict of Interest, IRB, IACUC, etc.).
  
• Knowledge of intellectual property law (copyright, patent).
  
• Rapid proficiency in the use of University of Chicago systems such as AURA and a high level of proficiency in Excel.
  
• Strong computer skills including word processing, database management and spreadsheet skills (Microsoft Office suite and Adobe suite).
  

Preferred Competencies

• Proven ability to grasp complex legal and business issues.
  
• Superior communication, drafting, and negotiation skills.
  
• Excellent collaboration skills with a strong customer focused approach.
  
• Comfortable with scientific concepts and terminology; understand the significance of various agreement terms in view of the nature of the materials/confidential information to be transferred and proposed research.
  
• Strong reading and analytical abilities and detail oriented and organized.
  
• Excellent verbal and written communication skills.
  
• Demonstrated maturity and sensitivity to the needs of multiple constituencies in a complex academic environment.
  
• Balance priorities, meet deadlines, and adjust to shifting priorities when needed.
  
• Demonstrated comprehension of University policies to ensure compliance, as well as to identify when appropriate to request exceptions. Self-motivated and work independently with strong administrative/problem solving skills.
  
• High level of creativity, energy, integrity, thoughtful judgment and problem solving, decision-making, and teamwork.
  
• Willingness to learn new skills, take on new challenges, and effectively interact and collaborate with all levels of University administrators and faculty members.
  
• Provide excellent customer service while maintaining a demeanor of civility and professionalism at all times.
  

Working Conditions

• Make decisions independently that will have downstream impacts on the management of clinical trials.
  
• Manage detail-oriented workload, organize and prioritize during high-pressure, high-volume periods and manage stress.
  
• Work on multiple projects simultaneously, set priorities, and meet deadlines.
  
• Exercise sound judgment and absolute discretion regarding confidential matters with tact.
  
• Interact by phone, email, online meetings or in person with faculty and administrative staff at the University and occasionally with staff of federal government, non-federal sponsors, and other institutions and organizations.
  
• Stay current with technology and digital tools.
  
• Sit for 4 hours or more.
  
• Use computers extensively for 4 hours or more.
  
• Use standard office equipment and troubleshoot IT equipment in a hybrid environment.
  

Application Documents

• Resume/CV (required)
  
• Cover Letter (preferred)
  

When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Financial Management

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

37.5

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at:http://securityreport.uchicago.edu.Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

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