|Job type||Full Time|
The UMN has suspended hiring for most positions. However, we will continue hiring for positions critical to the University's mission and operations at this time. Applications are being accepted for this position and you are encouraged to apply. In-person interviews are suspended indefinitely and will be replaced by interviews in a virtual format. Thank you for your continued interest in working at the University of Minnesota.
• BA/BS with at least six years of experience or an advanced degree with four years of experience with clinical and/or translational research
• Experience with regulatory aspects (e.g. IRB and FDA) of conducting clinical research
• Experience in the management of resources and research projects
• Experience leading teams and delegating or assigning work tasks
• Experience working with diverse populations
• Experience with computerized data management in a healthcare setting, including electronic medical records
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Demonstrated ability to maintain deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification or equivalent or ability to obtain certification within 6 months of hire
• Master's degree in a science or health-related field
• Experience working in an academic medical setting
• Advanced level skills in Microsoft Word and Microsoft Excel
• Budgeting/contracting experience
• Experience in an oncology, BMT, pediatric, or other acute medical setting
• Ability to be an independent and collaborative leader
• Experience directly supervising and/or mentoring and training staff and students
• Experience with multiple aspects of clinical research: e.g. mixed-methodology studies, clinical/translational studies including sample collection coordination, and/or patient-centered outcomes research)
• Experience with coordinating research for underserved/under-resourced patient populations
About the Job
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.
The Program Manager:
• Serves as the primary contact for clinical research investigators and is responsible for leading the team assembled to facilitate the consideration, initiation, and conduct of research studies.
• Helps investigators determine what resources are needed to advance an idea and assist investigators in gaining access to these resources; including making connections with other researchers and resources available at the University or externally.
• Works with investigators to oversee the management and timely completion of research studies, including working with team members representing other functions (e.g., biostatistics, recruitment, informatics consulting, regulatory, finance, data management, study coordination, etc.).
• Assists investigators from the proposal phase through manuscript development and dissemination of findings through community engagement by ensuring access to appropriate support resources.
• Possess an extensive knowledge of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and NIH research rules, which set the standards for the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials.
• Uses the knowledge and comprehension of the CFR, GCP, and NIH rules to apply them to protecting the safety and health of human subjects and meeting regulatory compliance requirements.
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 programs' 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, and reporting of clinical trials to protect the health and safety 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 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.
o Ensure required observations are performed and research specimens are collected per protocol requirements.
o 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.
How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.
To request an accommodation during the application process, please e-mail email@example.com or call (612) 624-UOHR (8647).
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.
Background Check Information
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), 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 offers a comprehensive benefits package, including:
For more information regarding benefits: https:// humanresources.umn.edu/sites/ humanresources.umn.edu/files/ 2020_tcd-fpa-75100-ben-0105- 10_cs_final.pdf
|Employer||University of Minnesota|