Senior Research Contract Analyst

Profile

Senior Research Contract Analyst

The candidate works closely with investigators, study staff and corporate legal to negotiate with industry sponsors and university collaborators. Oversees many types of agreements to include clinical trial agreements, basic and translational sponsored research agreements, expanded access letters of agreement, collaboration agreements, data use agreements, consults agreements, professional services agreements, and confidentiality agreements, for research and services sponsored by industry, non-profit, and academic sponsors. Provides mentoring, training, and oversight to junior contract staff to ensure compliance and consistency to support organization and department goals. Partners 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 inquirees on pending agreements. Partners collaboratively with the firm's 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. Drafts and negotiates complex agreement types and projects to include site agreements, sub-contracts, expanded Access Letters of Agreement, Master Agreements, Consortium Agreements, and Membership Agreements. Consults with study staff, investigators and administration as necessary to understand the nature of projects and relationships to identify appropriate agreement terms and conditions. Ensures 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). Ensures compliance with internal policies, agency guidelines, applicable laws and regulations (including export control). Ensures that language related to publication confidentiality, intellectual property, insurance indemnification and subject injury reimbursement are compliant with institutional guidelines and policies. Maintains 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. Reviews and negotiates 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 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. Bachelor’s degree in finance, accounting or related field is required. Juris Doctor degree is preferred. Should have 5+ years experience in a legal position, (i.e. paralegal, attorney or in a position negotiating contracts) for an academic research institute, hospital, sponsor, or contract research organization (CRO).

Additional Information

Job Ref # 26422

Company info

Houston Methodist
6565 Fannin Street Suite D200
Houston
Texas
United States 77030
Website : http://www.houstonmethodist.org