GENERAL SUMMARY OF POSITION:
The Contract Administrator II, Terms Specialist has primary responsibility for the review and negotiation of activities under the purview of the UMass Center for Clinical and Translational Science Office of Clinical Research, including industry sponsored Clinical Trial Agreements (CTAs), clinical research funding or support agreements, amendments, subcontracts, Confidential Disclosure Agreements (CDAs) and non-funded clinical/human research agreements. Review and negotiate agreements to ensure compliance with institutional and applicable federal and state requirements, especially related to indemnification, subject injury, publication, protection of data/HIPAA, intellectual property, insurance, termination and Human Research Protection Program (HRPP) requirements. The Contract Administrator, II—Terms Specialist serves as the primary point of contact with non-federal sponsors for agreement-related matters and coordinates activities/works closely with associated units such as Research Funding Services, Office of Technology Management, Departmental Administrators and Investigators. Consults with UMass Office of General Counsel on as-needed basis.
MAJOR RESPONSIBILITIES- TERMS SPECIALIST:
- Represents UMass Medical School to Industry and non-federal sponsors in negotiation of clinical research funding agreements;
- Provides information about institutional positions, policies and requirements to funders as well as study teams/Investigators;
- Coordinates with Contract Administrator II—Budget Specialist, Contract Administrator III and department/study team on negotiation of budget terms for associated agreements and provides cross-coverage to Contract Administrator II and III as necessary;
- Log, review, track and negotiate agreements and amendments in accordance in a timely manner; reviewing for accuracy, completeness and adherence to institutional positions, requirements and policy as well as applicable state, federal and other law or regulation;
- Monitor negotiation timelines in adherence to departmental goals and work with Investigators, Departments, Clinical Research Operations Manager and Study Teams to support expedited study initiation;
- Keep Principal Investigators, Department Administrators, Study Team and team members apprised of potential roadblocks and substantive contracting or budget negotiation issues;
- Prepare final documents for final review and execution by institutional signatory;
- Coordinate with Contract Administrator II—Clinical Budget Specialist, Contract Administrator III and department/study team on negotiation of budget terms for associated agreements;
- Coordinate with Clinical Research Operations Manager and study team/Investigator on issues of feasibility and implementation;
- Participate in pre-award training and educational outreach initiatives to faculty and UMMS staff. Assists in preparation of institutional training materials and presentations;
- Assist with the development and maintenance of all assigned written departmental policies and operating procedures.
- Recommend and implement process enhancement recommendations to support expedited project startup;
- Assist with web page content development and maintenance as directed;