Senior Contracts Analyst

University of Washington•Seattle, WA

About The Position

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 Office of Sponsored Programs (OSP), has an outstanding opportunity for a Senior Contracts Analyst (Senior Analyst). Reporting to the CTO Contracts Manager, the Senior Analyst is responsible for drafting and negotiating the terms of clinical trial agreements for clinical trials and research studies across all therapeutic areas. This position is responsible for drafting intricate and complex clinical trial agreements. These robust agreements cover a variety of complex contractual terms (intellectual property, payment terms, publication rights, subject injury, insurance terms, indemnification, amendments, dispute resolution, etc.). The Senior Analyst must maintain awareness of changes in regulatory policy, government policy and University policy to ensure that contracts are drafted with awareness of up-to-date rules and regulations. 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. The Senior Analyst is a key position in maintaining secure, efficient, and fully compliant clinical trials program at UW Medicine.

Requirements

Bachelor’s degree in science, healthcare, research, business administration or related field
Minimum four years of experience in grant and/or contract administration.
Additional experience may be substituted for the degree requirement
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
A demonstrated ability to work closely, collaboratively, and credibly with others
Knowledge of and experience with contract drafting, negotiation, and execution
Working knowledge of standard contract terms, such as confidentiality, intellectual property rights, and data ownership
Strong interpersonal and customer service skills
A demonstrated capacity to work with all people.
Excellent Microsoft Office suite skills

Nice To Haves

Master’s or Juris Doctorate degree preferred
Understanding of clinical trial start-up process and life cycle
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)

Responsibilities

Contract Review and Negotiation (90%) Review and evaluate terms and conditions for individual agreements, including complex Clinical Trial and Clinical Study Agreements, as well as Confidentiality Disclosure Agreements.
Timely and expertly negotiate mutually acceptable terms with large pharmaceutical and biotechnology corporations as well as large academic medical centers, site networks, private pharma and tech companies, foundations, non-profit organizations using multiple negotiation strategies and techniques.
Ensure that the negotiated terms are consistent with Federal and State law, University policy, processes, and systems, as well as originating sponsor or funder requirements.
Collaborate with physician investigators and departmental administrators and other representatives during negotiations.
Maintain target turnaround goals and transparency with study teams during contractual negotiations.
Consult with OSP colleagues to ensure consistent handling of agreements and use of contracts terms.
Maintain current and accurate agreement files of record.
Other duties as assigned.
Regulatory and Government Policy (10%) 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.