Research Support - Laboratory/Non-Laboratory, Staff/Administrative
In close partnership with the operations manager, this position is responsible for overseeing research operations across the department of Surgery. PGMs are responsible for the coordination of CTO study staff, investigators, sponsors, and provide oversight throughout the lifecycle of all clinical trials and research projects within the division. The PGM is integral in ensuring optimal resourcing and utilization of CTO, University of Minnesota, Fairview, and M Health resources. CTO Program Managers have extensive knowledge of the intricacies involved with clinical trial initiation, ongoing trial management, significant milestones, and required team deliverables (e.g., concept development, resource review and allocation, budgeting and contracting, regulatory reviews, data management.) The PGM position is a key element of the department's efforts to provide a one-stop shop for research questions and resources. Specific duties include:
1. Surgery Clinical Trial Portfolio Management and Oversight (50%) • 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 required to advance clinical research and assist 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, outside industry sponsors, cooperative groups, University consortiums, etc.). • Utilizes extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules to oversee CTO portfolio activities. 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. • 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. • Leads regular meetings with research staff, Principal Investigators and other pertinent stakeholders. • Increase designated CTO and department efficiency through monitoring staff workload and collaborate with hiring manager on both current and pipeline staffing requirements to project future resourcing needs. • Develops data collection instruments and procedures. Develop, manage, and maintain accurate databases, electronic records, and data warehouses.
2. Surgery CTO Operational Management (35%) • Direct supervision of the day-to-day workload activities of research staff, which may include but is not limited to 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. • Works with the HR manager to collaborate on interviewing, hiring of new employees, orientation and on boarding of new employees. This includes providing insight and decision-making related to employee orientation and onboarding plan, employee annual performance reviews, employee improvement plans and termination of employees. Authority to hire, transfer, promote, discharge, suspend, assign work, reward, discipline, and direct the work of employees. • Oversee the designated CTO team training development and mentoring plan for each team member. • Ensure UMN required systems are complete and accurate (OnCore, CTSI portal) • Provide ongoing education and training to faculty and staff on regulatory processes. • Oversee and ensure faculty are in compliance with clintrials.gov, Ethos 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 CTO Management 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 Surgery programs and strategic goals. This includes the Department of Surgery, Academic Health Center and University of Minnesota wide research programs.
3. Research Conduct Review and Compliance (10%) • Serve as a Quality Management resource • Oversee multiple process improvement projects within Clinical Trials Office (CTO) 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. • Reviews monitoring reports, data quality responsiveness, identifies and resolves problems with determined action plans with CTO processes and resourcing. • Leads audit teams, implements Corrective and Preventative Action (CAPA) plans. Perform liaison between the sponsor, investigator and governing body. • Along with the Operations Manager, assists with creation and maintenance of detailed clinical trial budgets/contracts and resolves budget deficits or financial queries. • Oversees completeness of Clinical Trials Management System-OnCore, CT.gov, and Division specific algorithms. • Actively participates in University of Minnesota research committees, such as Fairview Community site team, OnCore Service Group, CTO Operations group and department groups.
4. Publications Facilitation (5%) • Prepare and submit manuscripts, articles, abstracts, research reports, and presentations. • Collaborates with department administrators, grants management team, and division chairs to increase DoS visibility in scientific community • Source publication opportunities and manage deadlines
Also responsible for supervising 4 civil service employees.
Minimum Requirements: • Minimum Education: Bachelor´s Degree in a related field (i.e. business, nursing) • Minimum Experience: 6 years in clinical research and/or related business experience (or an advanced degree with 4 years of experience)
Preferred Qualifications: • Preferred Education: Master´s Degree • Certification: National certification in area of specialty or related area preferred. • Experience with OnCore clinical management system • Experience directing and managing staff • Previous experience in an academic setting
Internal Number: 333721
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.