Jr. Contracts Associate

University of Colorado Anschutz

Department: Office of Regulatory Compliance

Job Title: Jr. Contracts Associate

Position #:801559 – Requisition #: 40483

Job Summary:

This is a Clinical Research Contracts Associate position that will be assigned to review and negotiate sponsored research agreements focused primarily on industry-sponsored clinical trials, confidential/nondisclosure agreements (CDA/NDA), material transfer agreements (MTA), and similar contracting instruments. The incumbent will also work and cross train with the Office of Regulatory Compliance for the purpose of providing resources for the review of data use agreements/data transfer and use agreements (DUA, DTUA), Business Associate Agreements (BAA), and similar contracting instruments. The individual will be responsible for reviewing contracts to ensure compliance with University, State, and Federal policies and procedures and negotiating terms and conditions to meet these policies and procedures when applicable. The individual will report to the Clinical Research Contracts Manager and will be assigned to assist that position and other professionals in the office.

Key Responsibilities:

Contract Negotiation - 70%

• Serve as a Jr. Clinical Research Contracts Associate for the Clinical Research Administration Office located on the Anschutz Medical Campus.

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• Review and negotiate terms and conditions of industry sponsored clinical trial contracts, other contracts for human subjects research and related agreements (CDAs, NDAs, MTAs, Sub-awards) ensuring compliance with the Board of Regents, University, local, State and Federal policies including but not limited to: publication, indemnification, subject injury, AAHRPP, confidentiality, intellectual property, data ownership, etc.

• Review and negotiate terms and conditions of data use agreement (DUA, DTUA), business Associate Agreements (BAA), and similar agreements involving the transfer of data.

• Review and negotiate amendments to terms and conditions after original contract is executed.

• Appropriately identify and escalate issues to the Clinical Research Contracts Manager or Director of Regulatory Compliance.

• Communicate clearly and effectively with appropriate faculty and staff to ensure comprehension of final set of terms and conditions.

• Serve as a resource to other team members for questions on terms and conditions, negotiation best practice, issue spotting, and use of internal systems.

Process Development – 10%

• Provide input to the Clinical Research Contracts Manager and/or Director of Regulatory Compliance regarding development of practices and procedures in areas in need of development/improvement.

• Help identify, discuss, and solve workflow issues common to the clinical research contracts process.

• Help identify and create structures/practice for department outreach and relationship building.

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Special Projects – 10%

• Assistance is provided by attending meetings, researching issues, and drafting reports.