(Hybrid) Data Use Agreement (DUA) Coordinator - WV Clinical & Translational Science Institute
The West Virginia Clinical & Translational Science Institute at West Virginia University Research Corporation is currently accepting applications for a Data Use Agreement Coordinator.
About the Opportunity
As a Data Use Agreement (DUA) Coordinator, you will support the clinical trials contract negotiation team. You will serve as the primary reviewer for data use agreements (DUAs), including related documentation. This position prefers knowledge of WVCTSI, West Virginia University (WVU), and WVU Medicine policies and procedures as relates to data sharing and storage. You will report to the Director of Contract Negotiation with guidance also from Director of Clinical Research Data Analytics. You will follow data management standards, procedures, and documentation using knowledge of the healthcare regulatory environment to ensure conformance to internal and external policies, protocols, and regulations such as HIPAA. This position requires expert level knowledge of Protected Health Information (PHI) and its allowable use for research purposes. You should have knowledge of Health Insurance Portability and Accountability Act (HIPAA) identifiers and their deidentification as set forth by the Safe Harbor Method.
This position is hybrid. You will work from the WVCTSI main office in Morgantown, WV approximately 3 days per week and remotely 2 days per week. Schedule flexibility is available with discussion.
At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:
- 13 paid holidays (staff holiday calendar)
- 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
- A range of health insurance and other benefits
- Dependent Education Scholarship
- WVU Perks
- And More!!
What you'll do:
- Review data use agreements, HIPAA waivers of consent, and other compliance forms related to data use and data protection to ensure that they apply with federal, state, and local policies and procedures.
- Provide feedback on submissions that do not meet the outlined requirements and work with local and external research teams to assist the documentation in reaching compliance.
- Maintain expertise in WVU Office of Human Research Protection (OHRP) and WVCTSI services and policies to effectively communicate to researchers and accurately review submissions.
- Maintain up-to-date knowledge on guidance from Health and Human Services, the National Institutes of Health, and other regulatory bodies, and participate in the updating of processes based on new guidance.
- Respond to communications such as emails, calls, and submissions in a timely manner.
- Communicate with researchers regarding project feasibility and timelines.
- Collaborate with staff from WVU Medicine, OHRP, WVCTSI, General Counsel, and others to understand research requirements, discuss and implement process updates, and track project statuses.
- Assist with evaluation activities such as tracking and reporting for quarterly and annual reports.
- Provide assistance to management with functions such as planning, organizing coordinating, scheduling and implementing project activities to meet objectives.
- Create training and guidance documentation, Standard Operating Procedures, and other reference materials for data compliance processes.
- Follow data management standards, procedures, and documentation using knowledge of the healthcare regulatory environment to ensure conformance to internal and external policies, protocols, and regulations such as HIPAA.
- Maintain security and confidentiality of patient information.
- Other duties as assigned.
- Bachelor's degree in public administration, public health, legal studies, or other related field, or an equivalent combination of education and experience.
- A minimum of three (3) years of experience with clinical research activities, research compliance/regulation, or related experience, or an equivalent combination of education and experience.
- Background in or strong familiarity with clinical research compliance and regulation.
- Familiarity with HIPAA.
- Strong communication, organization, and prioritization skills.
- Effective time management skills at meeting deadlines.
- Demonstrated ability to present information and respond to questions from groups or individuals.
- Skill in organizing resources and establishing priorities.
- Demonstrated ability to create and produce clear, concise paper and electronic documents.
- Group facilitation, mediation, and conflict resolution skills.
- Demonstrated ability to work in a multidisciplinary team environment and to coordinate participation of team members from various backgrounds.
- Demonstrated knowledge and skill in using Microsoft Office Suite.
- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar, and the ability to communicate clearly.
- Strong analytical problem-solving skills.
- Maintains skills in, or knowledge of, professional principles, legal and/or reporting requirements affecting area of responsibility.
- Ability to troubleshoot entry level hardware and software problems.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of customers or employees of the organization.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Master's degree in public administration, public health, law, or related field.
- Familiarity with WVCTSI and/or higher education/research at academic medical centers.
- Certifications in research compliance and regulation.
About Research Corporation
The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
Creating an inclusive, engaged, and dynamic environment is core to WVURC's mission. We welcome candidates who can contribute a range of ideas, approaches and experiences.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: Feb 5, 2024
Posting Classification: Research Corporation
Exemption Status: Exempt
Benefits Eligible: Yes