Senior Contracts Analyst - School of Medicine, Clinical Trials Office

University of Washington•Seattle, WA

1d•Hybrid

About The Position

The Clinical Trials Office (CTO) has an outstanding opportunity for a Senior Contracts Analyst to join their team. Reporting to the CTO Contracts Manager, the Senior Contracts Analyst (Senior Analyst) is responsible for drafting and negotiating the terms of clinical trial agreements for clinical trials and research studies across all therapeutic areas. 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.

Requirements

Bachelor's degree in science, healthcare, research, business administration or related field.
Four or more years of experience in grant and/or contract administration.
Demonstrated ability to effectively manage a heavy work portfolio with competing priorities.
Strong analytical skills, problem-solving skills and attention to detail.
Demonstrated ability to work closely and collaboratively, using strong interpersonal and customer service skills.
Excellent Microsoft Office Suite skills.
Understanding roles and responsibilities at a large research academic center.
Knowledge of contract terms and experience with contract drafting, negotiation and execution.

Nice To Haves

Master's or Juris Doctorate degree.
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

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.
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.