Senior Clinical Trials Officer - Chicago, United States - University of Chicago

Description

Department

Provost


URA:
Research 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:* 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 required 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).

Preferred Competencies

• Excellent collaboration skills with a strong customer focused approach.
• 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.
• Must possess strong reading and analytical abilities and be 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.
• Prioritize and meet deadlines and adhere to University policies, raising questions when necessary.
• Self-motivated and able to work independently with strong administrative/problem solving skills.
• High level of creativity, energy, integrity, thoughtful judgment and problem solving, decision-making, and teamwork.
• Learn new skills, take on new challenges, and ability to effectively interact and collaborate with all levels of University administrators and faculty members.
• Customer service is a high priority of the office with a demeanor of civility and professionalism at all times.

Working Conditions

• Make decisions independently that will have downstream impacts on the management of sponsored projects.
• Manage detail-oriented workload, to organize and prioritize workload during high-pressure, high-volume workload periods and to manage stress.
• Exercise sound judgment, absolute discretion regarding confidential matters discretion, and tact.
• Handle multiple, concurrent tasks.
• Interact by phone, email 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.
• Sit for 4 hours or more.
• Use computers extensively for 4 hours or more.
• Travel to various on-campus locations on a daily basis.
• Use standard office equipment.
• Occasional travel.

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

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 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.

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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.

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