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Contracts Officer and Corporate Counsel
Closing Date: Dec. 30, 2009
| Employer: | KUMC Research Institute |
| Job Location: |
Kansas City - Wyandotte County |
| Employment Type: | Full Time |
| Salary Range: | Commensurate with education and/or experience |
Description: | This position will provide legal and administrative services pertaining to all aspects of clinical trials, sponsored research transactional agreements, collaboration agreements, investigational new drug applications, and other research-related agreements. In collaboration with other departmental personnel, reviews, drafts, and negotiates all research contracts, subcontracts and other transactional documents. At the discretion of the Executive Director, KUMC Research Institute/Associate Vice Chancellor for Research Administration, KUMC, he/she will prepare legal documents and provide legal advice to KUMC Research Institute management as well as designated affiliated entities of the University of Kansas on a wide variety of issues arising from research contracts, grants, compliance and other transactional agreements.
The Contracts Officer and Corporate Counsel will be responsible for cultivating and maintaining relationships with federal and state research agencies, corporate research organizations, foundations, private research entities and other universities and research institutions involved in basic and clinical research. May be asked to participate in special projects under the direction of the Executive Director, KUMC Research Institute/Associate Vice Chancellor for Research Administration, KUMC. Must have the ability to work independently in a team environment. Active member of the Research Institute senior management team.
| Duties: | Develop, review, and negotiate all research contracts, clinical research agreements, collaboration agreements, various intellectual property agreements and subcontracts pursuant to University policy.
Supervise attorneys and legal staff of the Contracts Division and establish/manage Division budget.
Supervise legal files and manage correspondence with contract entities.
Supervise tracking contract requirements and obligations, deadlines, events, and payment issues.
Interface with faculty and legal counsel in private for-profit and non-for-profit corporations and with University General Counsel Office.
Provide advice and recommendations to the Research Institute Board of Directors as requested by the Executive Director, KUMC Research Institute/Associate Vice Chancellor for Research Administration. Review for Good Clinical Practice compliance and compliance with local and federal laws, all clinical trial agreements, protocols, and consent documentation in accordance with University policy.
Review and assist with development of Investigator Initiated study agreements including set up and assistance with investigational new drug applications.
Develop and advise on appropriate research policies and procedures and coordinate with the Office of University Compliance on compliance policies impacting clinical research, conflict of interest, and coordinate with the Office for Human Research Protections (OHRP) standards in human clinical trials.
Advise and be knowledgeable on Food and Drug Administration (FDA) regulations impacting research and assure compliance with applicable regulations.
Provide legal counsel to the Executive Director, KUMC Research Institute/Associate Vice Chancellor for Research Administration, KUMC regarding a variety of legal issues with an emphasis on human clinical trials, non-profit, human resource, Food and Drug Administration (FDA) and ICH-GCP and research and/or technology issues.
Litigation support and oversight.
| Qualifications: | Education Requirements:
B.A./B.S. plus an earned JD degree from an ABA accredited law school.
Licensed in Kansas or capable of becoming licensed in Kansas. Membership in Missouri or other State Bars a plus.
Required Qualifications:
Attorney with five (5) years of research contract work or legal work in a research, higher education or healthcare related field.
Prior experience in one or more of the following areas: contract development, negotiation, oversight, clinical trials administration experience, new drug application or investigational new drug application preparation experience, human subjects protection, compliance and policy development.
Excellent communication skills, both oral and written.
Candidate must be self-motivated, an independent thinker, and possess strong document drafting, version control and negotiation skills, and display an attention to detail. This is a challenging position requiring excellent organizational skills, computer proficiency accuracy, management skills, and the ability to cultivate a variety of relationships both internal and external to the organization.
Preferred Qualifications:
Knowledge of the federal contracting process, federal grant and cooperative agreement regulations, OMB Circulars, and the Federal Acquisitions Regulations.
Previous export control experience. Working knowledge of Export Administration Regulations (EAR).
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