GENERAL SUMMARY OF POSITION:

Under the general direction of the Director or designee, the Team Lead, Clinical Research Agreements  provides oversight to the review and negotiation of industry clinical trial agreements, including terms and budgets/or sub-awards for the institution.  Actively facilitates and negotiations partnerships with industry and sponsors.  Serve as escalation point for sponsor negotiations.  Ensure contracts are negotiated in line with institutional and governmental requirements.  Serve as key resource for internal and external customers providing guidance and information on contractual matters to ensure requirements for contracts are meet.  Implement training and education programs for University of Massachusetts Medical School (UMMS) community.  Supervise staff as assigned.

MAJOR RESPONSIBILITIES:

• Review and negotiate Clinical Trial Agreements and research agreements with sponsors on behalf of the University, reviewing for accuracy and completeness while applying a comprehensive understanding of legal and University policies.
• Advise faculty and UMMS staff on negotiation bottlenecks, problematic terms and agreement requirements.
• Ensure all relevant documents are in compliance with respect to institution policies, federal regulations, state regulations and sponsor guidelines.
• Prepare and process agreement amendments.
• Facilitate budget negotiation, working closely with study teams and departmental administration and reviewing budget to ensure patient care costs and institution costs are adequately represented
• Resolve conflicts and facilitate contract through discussions and correspondence with sponsors and legal personnel, University counsel, faculty and staff.
• Work with Office of Technology Management regarding intellectual property issues during negotiation of confidentiality agreements and industry contracts.
• Work with Office of General Counsel
• Monitor review timelines and work to identify and resolve process bottlenecks to ensure timely negotiation to support rapid study start up;
• Prepare and analyze negotiation metrics, and facilitate dissemination of metrics to UMMS community;
• Receive and coordinate requests to add new sponsors into PeopleSoft and the Clinical Trials Management System (CTMS)
• Oversee and monitor budget building and financial pre-award work in the CTMS
• Work with team to develop best practices and guidance documents
• Develop and update resource materials for website and for sponsor correspondence;
• Participate in pre-award training and educational outreach initiatives to faculty and UMMS staff. Assists in preparation of institutional training materials and presentations.
• Perform other duties as required.

• MINIMUM QUALIFICATIONS:

  • Bachelor’s degree in Business Administration, or equivalent
  • 5 years relevant experience or equivalent
  • High level of oral and written communication skills with ability to interpret and communicate policies effectively
  • Demonstrated problem solving skills with ability to recommend alternative solutions to complex issues with the capability of persuading others toward a course of action
  • Advanced computer skills including Microsoft Office software, web searching, database applications, and information retrieval. PeopleSoft knowledge helpful. 
  • Excellent organizational and time management skills including the ability to manage multiple projects
  • Excellent interpersonal skills including the ability to prioritize, problem solve and work under pressure in a deadline oriented environment
  • Demonstrated ability to act with discretion and judgment and maintenance of confidentiality.

PREFERRED QUALIFICATIONS:

• OnCore & EPIC experience strongly preferred.
• Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
• OnCore Financial and Management Certifications preferred.