Industry Contract Officer
This job is no longer active.
View similar jobs.
POST DATE 8/12/2016
END DATE 10/8/2016
University of California - Los Angeles Medical Centers
Los Angeles, CA
JOB DESCRIPTIONJob Title:
Industry Contract Officer
M-F 8 am to 5 pm
Weyburn-Los Angeles, CA.
$33.52 / $5833
$65.13 / $11333
Layoff Referral Deadline:
The mission of the DGSOM Clinical Trials Administration Office (CTAO) contract team is to facilitate high quality clinical research that contributes to science and the introduction of new drugs, devices, treatments and procedures, while protecting the University and its faculty and employees from undue risk and liability and preserving intellectual property and publication rights. Reporting to the Director of CTAO the Contract Officer is responsible for providing contracting services for industry-sponsored clinical trials of drugs and medical device research projects. The Contract Officer has primary responsibility for: providing consulting services to faculty seeking funding from industry; understanding evolving trends in clinical trial research, developing and negotiating contracts with industry sponsors on behalf of the Regents for financial support of such programs; and providing on-going administrative management services for the UCLA investigator and the Sponsor during the term of the contract, e.g., extensions and providing interpretations of the contract. The high quality delivery of services to investigators in an efficient and customer service oriented manner is an important role, as well as complying with institutional requirements and industry standards and building effective relationships with industry sponsors.
A successful candidate will have demonstrated experience in problem solving and adapting policy considerations to negotiate and draft unique terms and conditions for clinical trial agreements. Negotiation and drafting focus will be on terms related to intellectual property, indemnification, regulatory & compliance issues.
Develops and negotiates clinical trials agreements with pharmaceutical and biological companies, and medical device manufacturers for the health sciences campus
Reviews all required approvals for the project, e.g. commitment of space or other resources, IRB, use of Medical Center resources such as the Clinical Research Center, Pharmacy, etc. Independently determines when exceptions to policies are warranted and prompts review and approval of the Director and other UCLA or Office of the President authority for policy deviations and exceptions, as directed.
Performs risk analysis of contracts and special or unique circumstances. Reviews contract and other legal documents prepared or proposed by industry sponsors to identify terms and conditions which do not adequately protect the investigator s or the University s rights, do not adequately address the responsibilities of both parties, or are otherwise inconsistent with the University s policies or objectives.
Conflict of Interest/Financial Disclosure Review and Analysis: Analyzes financial disclosures submitted by UCLA researchers describing their financial and/or management relationships with outside entities and the way in which the relationship may relate to their proposed University research activities. Reviews research and clinical trial contracts, licensing agreements, and other documents to identify potential conflicts of interest. Ascertains if additional information is needed in order to provide complete background information on the nature of the disclosed interest to the Institutional Conflict of Interest Committee. Produces appropriate documentation for negative disclosures. Provides direction and quality assurance review of associated work delegated to Contracts Analysts.
Reviews final terms and conditions with, and obtains approval from Principal Investigator and, as necessary, other investigators or contract personnel, to verify understanding of University s obligations and responsibilities, prior to execution of contracts. Under unusual circumstances, solicits reviews and approval of other administrative or academic officers. Independently determines when exceptions to policies are warranted and prompts review and approval of the Director, and other responsible UCLA or Office of the President authority under the direction of the Director, for policy deviations and exceptions.
Negotiates contract terms with sponsor. Proposes additional terms and conditions, or modifications of contract provisions where necessary.
Obtains appropriate signature on all contractual documents from only those with official UCLA delegated authority to sign contracts.
Maintains contact with UCLA investigators throughout course of the negotiations and consults as necessary. Aggressively pursues prompt review of modification of contract terms with legal and business representatives of the Sponsoring Company. Investigates any unusual delays and when appropriate, advises investigators, Deans and other UCLA administrative officers of unusual delays. Works productively and aggressively to meet established turnaround time standards, whenever possible.
Functions as resource for, and advisor to, UCLA investigator(s) and Departments/Schools during the term of the agreement. Takes necessary actions to assure that Sponsors meet obligations anticipated which bear upon the conduct of collaborative work, or are essential requirements for Investigator s performance or meeting timelines (e.g., shipment of equipment, provisions of technical resources and support personnel, etc.).
Education: Bachelor s Degree.
Education: Law Degree or paralegal training. (Preferred)
Experience: 5 years of experience (or equivalent education and experience), including at least 2 years in sponsored research contracting.
Knowledge of University policies, Federal and State regulations, and industry standards relating to contract authority, use of human subjects, research regulatory compliance requirements, subject injury and indemnification, intellectual property, copyright and patent law, publication rights, HIPAA and privacy, access to records, appropriate overhead rates, coverage analysis, stewardship responsibilities, academic personnel, the appropriate use of University facilities, etc. and the ability to develop expertise on many such policies.
Sufficient professional experience, education, business acumen, judgment and integrity to effectively serve investigator and sponsor clients, yet represent and advance the best interest of the University.
Ability to work in an environment with turnaround time and other goals that contribute to high quality customer service. Ability to efficiently and effectively prioritize and manage workload, meet expected turnaround time goals on an ongoing basis and monitor, analyze, and continue to improvements to the contracting processes on an ongoing basis. Ability to manage priorities of assignments to complete work in a timely manner when there are changes in workload, pressures of deadlines, competing requirements and changes in assignments.