The Research Contract Negotiator is responsible for independently reviewing, drafting and negotiating health research contracts and other related agreements with commercial companies, nonprofit healthcare organizations and academic institutions that sponsor or collaborate with Kaiser Permanente in conducting health research and clinical trial studies. Close collaboration with KP research, finance and administrative staff is required to identify, resolve and mitigate material privacy, compliance and business risks associated with each research study. Excellent written and oral communication skills and workload management capabilities to effectively complete in-bound and out-bound research contracts in a timely way.
Negotiate research contracts: Independently review, draft and negotiate various contracts with commercial companies, nonprofit healthcare and academic institutions, including research agreements, clinical trial agreements, data use and material transfer agreements, business associate agreements, non-disclosure agreements and other ancillary agreements necessary for the conduct of research, utilizing training, experience, approved language templates and modules. Review and analyze study protocols and other documents to formulate appropriate areas to address in contract negotiations. Independently conduct and complete negotiations in a timely way with minimal supervision, except when required for legal or other advice on KP policies on specific contract issues.
Effectively collaborate with KP research stakeholders and customers in all KP regions. Advise regional research administrators and investigators regarding contractual issues as requested. Participate in and contribute to KP and industry association workgroups and committees focused on research contracting and administrative processes. Assist in development of efficient work processes, research contract templates, tools and other materials to facilitate the timely execution of research contracting at KP. Maintain and submit accurate reports of contract negotiations using available tools and systems.
Human Subject Protection and Institutional Review Board Legal Support. Serve on KP Institutional Review Board(s) if and as requested. - Conduct expedited IRB reviews on research studies as requested by the Regional IRB Administrator or the IRB Chair. Act as liaison with Investigators and respond to questions/issues that arise. Review and edit monthly IRB minutes in support of IRB Administrators if requested. Consult on research issues, study construction, consent documents, surveys, etc., as requested by investigators, IRB administrators and staff. Liaison with KP legal counsel on issues as required.
Minimum five (5) years of experience in drafting, revising and analyzing research grants and contracts, including clinical trial agreements, subcontracts, data use and material transfer agreements and non-disclosure agreements.
Minimum five (5) years of experience in negotiation of federally-funded and privately sponsored research grants and contracts.
Minimum five (5) years of experience in grant, contract and subcontract administration and performance issues.
Minimum five (5) years of experience in the application of HIPAA, data privacy and security, financial compliance and human subjects protection requirements.
Bachelor's degree in business administration, arts, public health, public administration degree or four (4) years of experience in health, clinical and/or biomedical research contract negotiation required.
High School Diploma or General Education Development (GED) required.
License, Certification, Registration
Minimum seven (7) years of developing and negotiating complex legal agreements in a variety of settings including business, government, specializing in research administration.
Minimum seven (7) years of working directly in contract development, and negotiation in both federal and private sectors. Ability to develop and negotiate a variety of legal agreements including contracts, federal assistance agreement sub awards, Data Use Agreements, Material Transfer Agreements, and
Memorandum of Agreement documents all preferably in a research environment
Ability to work as a team member with key staff from multiple scientific and administrative functional areas.
Master's degree in business administration, arts, public health, public administration or other applicable advanced degree/certification.
Minimum seven (7) years of drafting, revising and analyzing research grants and contracts, clinical trial agreements, subcontracts, data use and material transfer agreements and/or non-disclosure agreements preferred.
Minimum seven (7) years in negotiation of federally-funded and privately sponsored research grants and contracts preferred.
Minimum seven (7) years of grant, contract and subcontract administration and performance issues preferred.
Minimum seven (7) years with application of HIPAA, data privacy and security, financial compliance or human subjects protection requirements preferred.
Master's degree in business administration, arts, public health, or public administration preferred.
Juris Doctor degree preferred.
Paralegal certificate preferred.
Primary Location: California,Oakland,1800 Harrison 1800 Harrison Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:00 AM Working Hours End: 5:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Individual Contributor Job Category: Research and Development Department: Kaiser Foundation Research Institute Travel: Yes, 5 % of the Time
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