Department:
RI Research Contracts Office -----
Research Contracts Department Position Title:
Research Contract Analyst - Research Administration Job Family Group:
Professional Staff Job Description Summary:
Under the direction of the Director of the Research Contracts Office, the Research Contracts Analyst performs all manner of research contract management services, in support of both clinical and non-clinical research funded internally as well as by pharmaceutical/biotechnology corporations, federal agencies, and foundations, among other sponsoring entities. The Research Contracts Analyst performs such services semi-autonomously as is commensurate with their experience and knowledge of complex contracting issues. Job Description:
Key Roles and Responsibilities:
Draft, review, revise, process and negotiate all manner of Research Agreements, including but not limited to Clinical Trial Agreements, Investigator-Initiated Study Agreements, Collaborative Research Agreements, Data Use Agreements, and Material Transfer Agreements. Primary responsibilities include but are not limited to the following:
Perform detailed analysis and editing, including drafting alternative and/or compromise language of all assigned incoming agreements based on comprehensive understanding of substantive legal issues presented.
Work with Researchers and their external collaborators/funders to understand their research projects in order to select the appropriate agreement type. Once established, draft and negotiate such agreements.
Negotiate substantive contract language with external parties with the goal of maximizing benefit and reducing risk to KUMC/UKHS.
Provide analysis, editing and negotiation support to Clinical Trial Budget Analysts with regards to substantive legal language embedded in payment/compensation terms.
Work with Director of Research Contracts Office and KUMC General Counsel’s Office to develop preferred contract language, guidelines, policy and standard operating procedures
Maintains positive and collegial relationship with Office of Clinical Trials Administration’s Budgets and Portfolio Management teams. Assures coordination of contracting and budgeting activities, including assisting with review and negotiation of payment terms.
Works with Clinical Research Study Personnel to ensure negotiated Clinical Research Agreements’ terms are reflected appropriately in the informed consent forms; including but not limited to revising and negotiating Subject Injury language.
Assist both inter- and intra-departmentally to ensure that fully executed documents are in place and that notifications have been made to the correct parties to ensure a smooth transition to post-award parties.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education: Juris Doctorate
This position requires a formal degree in the cited discipline area(s) to ensure that candidates have the foundational knowledge and skill set required to perform the duties of the position. The level of degree is based on accreditation requirements, institutional standards of academic and professional excellence, alignment with peer institution benchmarks, and contributes to the credibility and effectiveness of the role within the university community.
Preferred Qualifications
Work Experience
Work experience revising and negotiating complex clinical research agreements
Experience in a Hospital or Academic Medical Center research institution
Clinical Trial Agreements management/negotiation experience and/or health law experience.
Experience of relevant laws, regulations, contract language, and…