Depending on the experience of the selected candidate, this position will be hired at the Research Administrator 2 or Research Administrator 3 level.

UCSD Layoff from Career Appointment: Apply by 08/19/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 08/28/19. Eligible Special Selection clients should contact their Disability Counselor for assistance.

The Office of Clinical Trials Administration (OCTA) has the responsibility and authority to negotiate and execute research agreements with industry partners who desire to sponsor and fund clinical research at UCSD. The department provides comprehensive review and negotiation of research agreements to determine compliance with University policies and applicable regulatory requirements in support of clinical researchers and administrators.

This position is located within the School of Medicine and is part of the UC San Diego Health Sciences organization which is a $1 billion dollar plus organization encompassing 16 departments (14 clinical, 2 basic sciences), 2 professional schools (School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences), 2 hospitals, and various other programs and units all dedicated towards fulfilling the Health Sciences missions of education, scientific research, clinical care, and community outreach.

As a top-ranking, future oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. We are looking for top talent that possess the personal characteristics of integrity, strategic thinking, intellectual curiosity, collaboration, and teamwork.

Under general supervision, this position develops and/or oversees research proposals, awards and/or transactions related to contract and grant management and maintains contract and grant records in compliance with institutional and research sponsor policies. Receives assignments on project basis and fully analyzes problems, gathers data and information, and recommends solutions. Completes and approves transactions for signature by manager or other authorized institutional official.

Specifically, the incumbent will exercise judgment within general guidelines and practices to analyze, draft, revise, and negotiate terms and conditions of contracts in support of industry sponsor (i.e. for-profit company) initiated and funded clinical trials and related human subject research projects. The responsibilities include but are not limited to negotiating Confidential Disclosure Agreements/Non-Disclosure Agreements (CDA/NDAs), Clinical Trial Agreements (CTAs) and related ancillary agreements and/or documents, Amendments, and other human subject related research agreements as necessary. Analyzes, drafts, revises, and negotiates payment terms as contained in such agreements. Manages a high volume of contracts from intake to execution and will be responsible for evaluating all agreements for conformance with UC/UCSD policies and practices in addition to applicable laws and regulations.

The incumbent will be responsible for communicating and negotiating directly with industry sponsors and contract research organizations (CROs), including their research associates, contract professionals, and legal counsel. Under general supervision, will advise and counsel both external parties and internal department administrators and principal investigators regarding sponsored projects administration and contracting processes at the University. Incumbent must possess strong organization and excellent verbal and written communication skills and demonstrated ability and experience explaining and persuading or negotiating complex issues with third parties within established policy or legal parameters. Must be able to identify issues and independently problem-solve with strong attention to detail.

• A Bachelor's Degree in related area; and/or an equivalent combination of experience/training.

• Two (2+) or more years of experience in contract negotiation; or relevant experience. To be considered at the Research Administrator 3 level, must have three (3+) or more years of experience in negotiating industry sponsored contracts.

• Demonstrated ability to manage a high volume of transactions.

• Knowledge of applicable federal, state, local, sponsor and institutional regulations, policies, and guidelines. Specifically, regulations regarding human subject research and clinical trials.

• Maintains current knowledge of compliance regulations in all areas of research administration. Specifically, as they pertain to human subject research and clinical trials.

• Knowledge of applicable compliance requirements related to use of human or animal subjects in research, financial conflict of interest, biosafety, etc.

• Demonstrated ability to interpret and apply laws, regulations, or written policies and procedures.

• Ability to maintain independent judgment; strong organization; communication skills; and a customer service focus.

JD or legal education/relevant job experience negotiating contract terms or performing a related task on behalf of a site/academic medical center or sponsor.

• Employment is subject to a criminal background check.
• Must be able to adjust work schedule to meet deadlines. Overtime may be required.