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Job Details

Senior Research Contract Analyst

Company name
Houston Methodist

Experience
5 yrs required

Location
Houston, TX, United States

Employment Type
Full-Time

Industry
Legal

Posted on
Dec 04, 2022

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Senior Research Contract Analyst

The candidate will provide mentoring, training, and oversight to junior contract staff to ensure compliance and consistency to support organization and department goals. Will partner with study staff, research administration and other internal partners to draft, negotiate, and finalize contracts and ensure investigator and institutional needs are met. This includes maintaining the highest level of responsiveness and service while communicating contract status updates to investigator and sponsor inquiries on pending agreements. Partners collaboratively with Houston Methodist General Counsel, Risk Management and all areas of HMRI Finance to ensure compliance with institutional policies and requirements. Serves as primary interface with industry sponsors in the negotiation process and correspondence. Independently manages a portfolio of sponsored project contracts on behalf of HMRI, which includes the development, review, negotiation, and execution of research-related agreements. Draft and negotiate complex agreement types and projects to include site agreements, sub-contracts, expanded Access Letters of Agreement, Master Agreements, Consortium Agreements, and Membership Agreements. Consult with study staff, investigators and administration as necessary to understand the nature of projects and relationships to identify appropriate agreement terms and conditions. Ensure regulatory compliance by monitoring safety committee approvals are in place, specifically for the Institutional Review Board, (IRB) and Institutional Animal Care and Use Committee, (IACUC). Ensure compliance with internal policies, agency guidelines, applicable laws and regulations (including export control). Ensure that language related to publication confidentiality, intellectual property, insurance indemnification and subject injury reimbursement are compliant with institutional guidelines and policies. Maintain thorough documentation in an efficient and organized manner to facilitate effective knowledge transfer by maintaining progress notes in Methodist Online Research Technology Initiative (MORTI) and diligently updating contract statuses for intake and tracking purposes. Review and negotiate favorable payment terms in research agreements which include ensuring compliance with institutional policies, federal regulations, institutional overhead, fee requirements, and internal budgets for clinical trials. Provides feedback on errors or issues with MORTI system and participates in process change considerations to impact contract turnaround times. Provides training to the team on special topics and/or new laws and regulations related to research contracts as requested. Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

Additional Information

Job Ref: 33221

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