About the Job
The primary purpose of this position is to coordinate and support our pediatric research initiatives in Peds Critical Care (PICU/CVICU) according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data, sample management, and responding to data queries. This position reports to the Clinical Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the research team.
*With your application, please include a cover letter that summarizes why you are interested in working with critically ill children.
Responsibilities:
Clinical Research Conduct & Facilitation (55%)
- Lead a large and/or complex project, or portfolio of projects with assistance of project manager or other leaders, as needed.
- Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
- Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue.
- Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
- Facilitate the timely review and reporting of adverse reactions and severe adverse events.
- Contribute to the production of research publications or presentations of research data.
- Lead study team meetings as well as meetings with stakeholders engaged in the clinical research study.
- Maintain overall knowledge of individual study tasks as well as higher level oversight of clinical research studies.
Research Regulatory Management (30%)
- Serve as the primary contact for the completion of required regulatory documentation.
- Prepare regulatory approval applications; respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions to ensure deadlines are met.
- In collaboration with the PI, interpret study protocols and develop consent form documents needed for each clinical research study.
- Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.
- Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations.
- Prepare for and participate in site qualification visits, site initiation visits, monitoring visits, program audits, etc.
- Report Unanticipated Problems according to University policy.
Administration & Education (15%)
- Facilitate new project development and start-up activities.
- Support quality improvement initiatives.
- Facilitate Pre-award and Post-award grant administration.
- Attend national professional organization meetings and investigator meetings as appropriate.
- Support the training and mentoring of CRCs within the program and across the pediatrics department.
- Educate University faculty and staff on our regulatory and research obligations in relation to pediatric clinical research activities.
- Communicate with and provide education to clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.
Qualifications
All required qualifications must be documented on application materials.
Required Qualifications:
- BA/BS in a scientific or health related field and 4 years research experience, OR advanced degree plus 2 years research experience, OR a combination of education and experience in research to equal to 8 years.
- At least 2-years' experience conducting clinical research, preferably at the University of Minnesota.
- Experience working with patients and families, preferably within a hospital setting and/or pediatric populations.
- Ability to work flexible work hours, including occasional evening and weekends.
- During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.
Preferred Qualifications:
- Relevant research certification, such as CCRP or CCRC.
- Effective prioritizing responsibilities with ability to change priorities with emerging needs.
- Demonstrated ability to maintain deadlines.
- Excellent written, verbal and interpersonal skills.
- Knowledge of federal regulations related to research with human subjects and protected health information.
- Experience with computerized data management in a health-related setting.
- Demonstrated specimen management skills, including processing human samples and shipping per regulations.
- Detail-oriented with exceptional organizational, planning and problem-solving skills.
- Ability to work independently and as a part of a team.
- Experience with Epic electronic medical record system.
- Experience with pediatric populations.
- Demonstrated data management skills, including data collection, generating reports, and ensuring data quality.
- Computer proficiency and ability to navigate multiple software applications.
About the Department
At the University of Minnesota's Department of Pediatrics, our expert care teams and researchers are illuminating cures and advocating for changes that save young lives. Our ground-breaking treatments and care are improving the lives of children and becoming the standard of care for children across the country and around the world.
The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) fostering a participant-centric research culture, 2) developing expert research professionals specialized in pediatric clinical research, 3) creating effective and efficient pathways for conducting clinical research that meets the highest of standards.
The Division of Pediatric Critical Care Medicine is dedicated to providing innovative care, conducting research, and teaching skills to recognize and treat the medical need of critically ill children.
Benefits
Working at the University
At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.
The University also offers a comprehensive benefits package that includes:
- Competitive wages, paid holidays, and generous time off.
- Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program.
- Low-cost medical, dental, and pharmacy plans.
- Healthcare and dependent care flexible spending accounts.
- University HSA contributions.
- Disability and employer-paid life insurance.
- Employee wellbeing program.
- Excellent retirement plans with employer contribution.
- Public Service Loan Forgiveness (PSLF) opportunity.
- Financial counseling services.
- Employee Assistance Program with eight sessions of counseling at no cost.
Please visit the Office of Human Resources website for more information regarding benefits.
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 employ@umn.edu or call (612) 624-8647.
Diversity
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
Employment Requirements
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.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).
The University of Minnesota Medical School
Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery. The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.
Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.
