Position Summary
This position plans, develops, implements, and manages operations for the Masonic Cancer Center, Cancer Survivor Program, and the Hematology Program in the Division of Pediatric Hematology/Oncology. These two programs are conducting innovative research studies including participants through the lifespan. This position will work collaboratively with faculty leadership to facilitate growth of these research programs. This position reports directly to the Pediatric Hematology/Oncology Division Administrator, but is accountable to the physician-investigators and the research team. In this position, you are designated as an Essential Employee. Essential Employees are expected to report to campus during a University State of Emergency (reduced operations or campus closure) unless specifically directed by the Department not to report or if directed by civil emergency or medical authorities not to report for health and safety reasons. As an Essential Employee, you must report to campus even if the closure is less than 3 days. Responsibilities
65% - Program Operations
?Lead and direct the day-to-day workload activities of regulatory specialists and clinical research coordinators, including prioritization of efforts related to the programsâ™ pending and active clinical research trials through the closing and termination.
?Perform the planning and implementation of resourcing needs required to advance clinical research for investigators 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 consortia, etc.).
?Utilize extensive knowledge and comprehension of CFR, GCP guidelines, and NIH research rules to oversee program activities. Apply them to the design, conduct, performance, monitoring, recording, analysis,
?Strategize, develop, and implement individual clinical research project plans including trial timelines, regulatory pathways, budgeting, and contracting plans for the life cycle of the clinical trial including real-time troubleshooting of barriers.
?Identify areas for process improvement and develop new standard operating procedures as needed.
?Serve as liaison with other UMP/Fairview departments and clinic settings to facilitate collaboration and resolution of operational issues related to managing research subjects and meeting research requirements.
?Create and maintain detailed clinical trial budgets/contracts and resolves budget deficits or financial queries.
?Plan for and support the development and growth of the research programs.
15% - Administration/Management
?Accomplish program objectives by supervising staff, organizing, and monitoring work processes.
?Mentor and train new and existing clinical research coordinator (CRC) staff for continued growth (CRC responsibilities include the following: entering data into an electronic data capture system, preparing/shipping lab samples, deviation reporting, adherence to protocol/ standard operating procedures/GCP, source document review and problem identification, working collaboratively with monitors/scheduling monitoring visits, consenting/re-consenting subjects as applicable per protocol and patient status, and any additional tasks as required).
?Measure and develop staff clinical and research competencies, including identifying and coordinating ongoing training needs.
?Facilitate collaborative problem solving and team building with staff to ensure optimal resource utilization and efficiency of day-to-day clinical trial operations.
?As needed, provide relief support to other CRC members of the research team. This includes: o Confirm eligibility of potential subjects and oversee study enrollments.
?Ensure required observations are performed and research specimens are collected per protocol requirements.
?Monitoring, coding, and reporting of toxicities and adverse events experienced by research subjects.
20% - Financial / Contract Management
?Independently or in collaboration with CTSI Budget Specialist, take responsibility for formulating and negotiating budgets for research studies and reviewing with the faculty principal investigator prior to negotiating with representatives from the sponsoring company or agency.
?Actively participate in developing grants, write non-scientific aspects of grants and contracts (budgets, justifications, scope of work, timelines, etc.), and manage grants and contracts per departmental processes. ?Manage execution of unfunded research agreements. Direct the process to ensure the agreements are processed efficiently and effectively.
?Work with foundation partners to write case statements, manage external relationships, identify new grant opportunities, etc.
?Develop and execute Contracts for Professional Services (CPS) for projects as needed. Develop and negotiate work scope and budget with external partners.
?Process NIH-funded subawards for clinical trial projects from other institutions. Work collaboratively with Pediatric Research Support Services to ensure paperwork is routed internally for approvals appropriately. Develop internal budgets for NIH subawards.
?Identify projects with anticipated deficits and develop a plan for covering anticipated deficits. ?Monitor clinical investigator financial portfolios post-award to ensure accuracy of accounting reports. Identify reasons for deficits and surpluses and identify solutions as needed. Required Qualifications
?BA/BS degree in appropriate discipline and at least six years of relevant experience or advanced degree with at least four years relevant experience
?Leadership experience
?Strong written and verbal communications skills
?Knowledge of quality systems requirements
?Computer knowledge and skills
?Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification, or equivalent (e.g. RAC) or able to obtain in first year of employment Preferred Qualifications
?Previous experience in a clinical research or academic medicine setting.
?Proficiency with OnCore.
?Advanced knowledge of Microsoft Excel and Word.
?Professional research certification (such as SOCRA or ACRP). 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.
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