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Senior Clinical Trials Officer

University of Chicago
Posted a month ago, valid for 15 days
Location

Austin, TX 78714, US

Salary

$120,000 - $144,000 per year

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Contract type

Full Time

Paid Time Off

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Sonic Summary

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  • The University of Chicago is seeking a Senior Clinical Trials Officer for the Clinical Trials Team within the University Research Administration, requiring 5-7 years of relevant experience.
  • This role involves drafting, negotiating, and managing complex clinical trial agreements while ensuring compliance with university policies and federal regulations.
  • The position offers a salary range of $95,000.00 - $120,000.00 and includes responsibilities such as providing research compliance education and collaborating with faculty and university leadership.
  • Candidates with a law degree or paralegal experience, along with a strong understanding of university research environments, are preferred.
  • The successful applicant will demonstrate exceptional communication skills, attention to detail, and the ability to work independently in a fast-paced environment.

Department

Provost URA: Clinical Trials Contracting


About the Department

University Research Administration 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 Senior Clinical Trials Officer position is the Lead on 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. The position will be focus on Clinical Trial Agreements including IIAs and Clinical Subsite Agreements. The job uses best practices and knowledge of activities to support the functional areas of University Research Administration. The individual will be expected to take a leading role in research, training, and other sponsored activities at the University, building upon knowledge of the University, processes, and customers. Assists in the development of research compliance education programs related to Clinical Trials.

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.

Reporting to the Director, Research Contracting this position will be an integral part of advancing faculty and Institute research initiatives in the Clinical Trial and Clinical Research space working closing with the Office of Clinical Research and University leadership.

Responsibilities

  • Works with the Director, Research Contracting to establish consistent and high level of service provided to faculty researchers and administrators by Clinical Trials Team.

  • 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 sponsor 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.

  • Works closely and collaboratively with University Leadership support of faculty and various University needs.

  • Works with colleagues and Associate Vice President for Research Administration to develop approaches and solutions for novel or atypical terms requested by faculty or potential sponsor.

  • 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.

  • 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.

  • With limited guidance, helps to obtain sponsor approvals for major changes to project work scope, etc. Transmits proposals and manages post award administration, 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.

  • Performs other related work as needed.


Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.


Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.


Certifications:

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Preferred Qualifications

Education:

  • Law degree strongly preferred.

Experience:

  • Paralegal or legal experience.

  • At least five 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.

Technical Skills or Knowledge:

  • Proven ability to grasp complex legal and business issues.

  • Proven ability to work effectively in support of business development and/or research administration and health care professionals.

  • 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).

  • Comfortable with scientific concepts and terminology; able to understand the significance of various agreement terms in view of the nature of the materials/confidential information to be transferred and proposed research.

Preferred Competencies 

  • Independence: Work independently with a high degree of initiative, curiosity and minimal supervision. Willingness to learn new skills, take on new challenges, and ability to effectively interact and collaborate with all levels of university administrators and faculty members. Make decisions independently that will have downstream impacts on the management of sponsored projects.

  • Communication Skills: Excellent oral and written communication skills with the ability to interact effectively with a diverse range of stakeholders, with faculty and administrative staff at the University, and close collaboration with all staff within the office of University Research Administration. 

  • Service Orientation: Positive, service-oriented attitude with a courteous demeanor, maintaining professionalism in all interactions. Ability to develop and manage interpersonal relationships.

  • Discretion and Confidentiality: Ability to handle sensitive and confidential situations with absolute discretion and maintain confidentiality. 

  • Attention to Detail and Accuracy: Exceptional attention to detail and thoroughness in completing tasks accurately. Work on multiple projects simultaneously, set priorities, and meet deadlines.

  • Organizational and Multitasking Skills: Strong organizational skills with the ability to multitask, meet deadlines, and navigate ambiguity in a fast-paced work environment. 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.

  • Judgment and Project Management: Sound judgment with the ability to prioritize and anticipate potential issues and address them proactively. 

  • Adaptability and Feedback Reception: Stay current with technology and digital tools. Ability to maintain composure under pressure, work flexible hours as needed, and respond constructively to feedback. 

Working Conditions 

  • Sit for 4 hours or more.

  • Use computers extensively for 4 hours or more.

  • Use standard office equipment and troubleshoot IT equipment in a remote/hybrid environment.

  • Travel to various on-campus locations when required.

  • Some evening and weekend work may be required.

Application Documents

  • Resume/CV (required)

  • Cover Letter (preferred)

  • References Contact Information (3)(preferred)


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


Job Family

Financial Management


Role Impact

Individual Contributor


Scheduled Weekly Hours

37.5


Drug Test Required

No


Health Screen Required

No


Motor Vehicle Record Inquiry Required

No


Pay Rate Type

Salary


FLSA Status

Exempt


Pay Range

$95,000.00 - $120,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.


Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.


Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.

 

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.

 

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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