Research - Laboratory/Non-Laboratory, Staff/Administrative
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UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SOM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.
The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.
The Clinical Trials Office, in partnership with the SOM Business Unit and the Office of Sponsored Programs (OSP), has an outstanding opportunity for a part-time Contracts Analyst (60% FTE). This position will be dedicated to processing sponsored research related confidentiality agreements for Cancer Consortium clinical trials and will have a dual report to the CTO Director and the SOM Business Unit Director of External Business Relations. This is a 60% FTE position.
Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on UW reputation with major global biotech and biopharma sponsors, the availability of funded clinical trial opportunities in UW pipeline, and UW patients' access to novel therapies. In addition, the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with the CMS and the FDA regulations and guidelines. CTO Contracts Analyst is a key position in maintaining secure, efficient, and fully compliant CTO operation.
Contract Review and Negotiation: •Review and evaluate terms and conditions for individual confidentiality disclosure (CDA) and other related agreements. •Collaborate with Department representatives and/or faculty during negotiations. •Negotiate acceptable terms that are consistent with Federal and State law, University policy, processes, and systems, as well as originating sponsor or funder requirements. •Consult with Business Unit and OSP contacts to ensure consistent handling of CDAs and use of contract terms. •Maintain current and accurate agreement files of record. •Other duties as assigned.
Regulatory and Government Policy: •Stay abreast of the changing regulatory landscape. •Maintain awareness of changes in UW, UW Medicine and funder policies and practices. •Evaluate and make recommendations for adjustments to policies and processes needed because of changes in regulations or overall funder policies and practices.
MINIMUM REQUIREMENTS •Bachelor’s degree and two or more years of experience and development of expertise in grant and/or contract administration. Additional experience may be substituted for the degree requirement.
Additional requirements: •Demonstrated ability to effectively manage a heavy work portfolio with competing priorities. •Strong analytical and problem-solving skills. •Attention to detail. •Understanding of roles and responsibilities at a large research academic center. •Demonstrated ability to work closely, collaboratively, and credibly with others. •Knowledge of and experience with contract negotiation, drafting, and execution. •Working knowledge of standard contract terms, such as confidentiality, intellectual property rights, and data ownership. •Strong interpersonal and customer service skills. •Demonstrated capacity to work with and within a diverse community. •Excellent Microsoft Office suite skills.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS •Some familiarity with clinical trials. •Working knowledge of sponsor types and differing sponsor requirements. •Knowledge of Federal regulations concerning management of Federal assistance funding, including the Uniform Guidance. •Knowledge of Federal acquisition processes and Federal Acquisition Regulations (FAR).
CONDITIONS OF EMPLOYMENT The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.