Senior Clinical Trials Officer

The Senior Clinical Trials Officer position is a lead on 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.

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

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

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

• Law degree strongly preferred.

• 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.

• 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.