Data Use Agreement Manager

POSITION OBJECTIVE

The Data Use Agreement Manager is responsible for the evaluation, negotiation, and processing of agreements related to data transfers to and from Case Western Reserve University. Data types may include everything from proprietary information to human subject data and be covered under an appropriate contract such as a Data Use Agreement (DUA), Data Transfer Agreement, and Research Agreements. Negotiation of these agreements is a highly technical task, both scientific and legal, and requires an understanding of and commitment to upholding human subject research laws and university policy governing the university’s position on a variety of negotiable terms while balancing the needs of faculty and staff.

ESSENTIAL FUNCTIONS

• Independently evaluate data use agreements. Review data sections of research agreements for sponsored projects administration as needed. Evaluate requests in terms of compliance, circumstances, terms and conditions, appropriate templates, language, legal implications, and more. Identify appropriate data risk level, Institutional Review Board (IRB) implications, and necessary revisions. Propose and facilitate appropriate amendments, (50%)

• Independently negotiate standard data use agreements. Negotiate diligently with external parties at companies, academic institutions, hospitals, and government agencies. Review university Institutional Review Board (IRB) research protocols for agreement compliance. Escalate complex nonstandard data use agreements to the director of contracts. (20%)

• Draft, circulate, and receive data use and data transfer documents. Track and record data use related agreements. Confirm data security plan compliance with University Technology data security personnel. Confirm compliance with Health Insurance Portability and Accountability Act (HIPAA) and other human subject protections. Secure legal approval from the director for contracts. Confirm compliance with university and federal export control regulations. Communicate with and educate faculty and staff about data transfer, data use and compliance with data use documents. Collect signatures and explain and distribute executed agreements to all parties. (15%)

• Provide input and recommendations on the creation, revision, and implementation of data use agreement process and the strategic direction of data use agreements guidance at the university. Maintain current information and understanding of federal regulations, ethical considerations, and university Institutional Review Board (IRB) and university research polices related to data and the protection of human research including knowledge of United States and European Union data protection and privacy laws, the Common Rule, Federal Demonstration Partnership, and other human data safety regulations. Inform and educate faculty, staff and students about these regulations, human subjects’ protections and data use and transfer. (14%)

NONESSENTIAL FUNCTIONS

Perform other duties as assigned. (1%)

CONTACTS

Department: Frequent contact with the director of contracts, the associate vice president for research, the executive director of IRB, technology transfer, and other department staff.

University: Frequent contact with faculty and staff to assist faculty and staff that require data related contracts to bring data in or send data out of the university and inform faculty and staff of the relevant data and human subject protections regulations that apply. Frequent contact with University Technology staff to assist faculty and staff with the contacts and requirements necessary to insure proper data security under University Technology’s guidance.

External: Frequent contact with external partners in industry, government, hospital, academic and not-for-profit sectors to draft, circulate and negotiate data contracts.

Students: Occasional contact with students, specifically graduate students, that need assistance with data use issues or agreements.

SUPERVISORY RESPONSIBILITY

None

QUALIFICATIONS

Bachelor’s degree and 5 or more years of related experience required; or Master's degree and 1 or more years of related work experience required. Knowledge of research compliance, grant administration, or contract negotiation preferred.

REQUIRED SKILLS

• Working knowledge of the discipline of social or biomedical science or human subjects’ research.

• Knowledge of Federal Demonstration Partnership.

• Working knowledge of Institutional Review Board (IRB) regulations.

• Competence to work with highly complex material, both legal and technical.

• Capacity to process work with a sense of urgency while being attentive to details.

• Ability to remain calm and deal with high-pressure situations diplomatically.

• Must be organized with demonstrated ability to work independently.

• Strong writing and oral communication skills.

• Ability to meet consistent attendance.

• Ability to interact with colleagues, supervisors, and customers face to face.

WORKING CONDITIONS

General office working environment on campus. Some in-person contact with faculty, staff, and students elsewhere on campus. Extended hours may be required.