Research Project Specialist

Minneapolis, Minnesota
University of Minnesota

The University of Minnesota is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation’s most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

The University of Minnesota s Department of Psychiatry & Behavioral Sciences is seeking a Research Project Specialist to lead research support activities.

This position will provide professional research and technical support for department research projects with emphasis on efficiency, compliance and advocacy in the design and conduct/flow of the research projects. The ideal candidate will apply subject matter knowledge, including research technologies, to ensure operational effectiveness; problem resolution necessitates considerable resourcefulness.

Serve as the professional expert for research related inquiries, manage research support personnel and work, oversee compliance and training.

Job Duties/Responsibilities:

20% – Research Portfolio Management

• Support research faculty: Serve as a resource to research faculty and staff throughout the life cycle of a study.
• Serve as point-person and provide guidance for investigators on resourcing needs in advancing clinical research and assisting investigators in gaining access to respective resources. This includes identification and coordination of internal and external stakeholders (e.g., biostatistics, recruitment, informatics consulting, regulatory, finance, data management, study coordination, external industry sponsors, cooperative groups, University consortiums, etc.).
• Strategize, develop, and implement individual clinical research project plans including trial timelines, regulatory pathways, budgeting and contracting plans for the life cycle of the research project.
• Lead regular meetings with research staff, Principal Investigators, and other pertinent stakeholders.
• Develop data collection instruments and procedures. Develop, manage, and maintain accurate databases, electronic records, and data warehouses.

60% – Operational Management and oversight

• Develop policies and procedures for staff to promote adherence to University, UMP, and MHealth policies. Consistently assure adherence to regulatory requirements to ensure patient safety and privacy, data safety, and the safety of research staff
• Utilizes extensive knowledge and comprehension of Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) guidelines.. Applies them to the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials to the protecting the safety and health of human subjects and meeting regulatory compliance requirements
• Reviews monitoring reports, data quality responsiveness, identifies and resolves problems with determined action plans OVPR processes and resourcing.
• Provide ongoing education and training to faculty and staff on regulatory processes.
• Ensure UMN required systems are complete and accurate (OnCore, ETHOS, and CTR Portal)
• Oversee and ensure faculty are in compliance with clintrials.gov and other regulatory portals.
• Designate or provide back-up coverage for leaves of absence and attrition to ensure coverage for funded projects.
• As part of the Dept Research Council Team, works with Department leadership to modify practices and procedures to improve efficiency and quality to enhance the development and growth of the Department of Psychiatry and Behavioral Sciences. Participate in strategic planning and program development as it relates to quality and safety in human subject studies .

10% – Fiscal Responsibility/ Compliance

• Oversee multiple process improvement projects within Clinical Trials Office and OVPR (Office of the Vice President for Research) utilizing knowledge of clinical trial workflow, federal and state regulations to develop new processes and procedures to aid in the advancement of research. Demonstrate an extensive knowledge of NCI designations, the FDA Code of Federal Regulations (CFR) and Good Clinical Practices, which set the standards for the conduct, performance, monitoring, recording, analysis, and reporting
• Leads audit teams, implements Corrective and Preventative Action (CAPA) plans. Perform liaison between the sponsor, investigator, and governing body.
• As needed, will provide support to team members in the creation and management of human subject budgets.
• Actively participates in University of Minnesota research committees, such as Fairview Community site team, OnCore Service Group, and department groups

10% – Provide guidance to faculty and leadership of research program

• Serve as a Quality Management resource to faculty researchers and research support team
• Provide insight and decision-making related to employee orientation and onboarding plan, employee annual performance reviews, employee improvement plans for research support team under Pi authority
• Be a subject matter expert support for the clinical trial specialists, research nurses, data coordinators and clinical research coordinators. This includes prioritization of efforts related to pending and active clinical research trials from start through the closing and termination.