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Position Summary
The primary purpose of this position is to coordinate and support our pediatric research initiatives according to regulatory requirements, institutional guidelines, and sponsor expectations in Pediatric Critical Care. Duties include initiating new research studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, 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.

Responsibilities

Study Coordination (70%)
* Coordinate a large and complex portfolio of research projects
* Coordinate patient participation in clinical research, including:
o Screening and recruiting patients and families
o Ensuring study eligibility and enrollment
o Scheduling and conducting research visits
* Data management for multiple projects, including:
o Data collection and entry into databases
o Ensuring data quality
o Supporting the PI and Developer in database development
* Specimen management for multiple projects, including:
o Coordinating the collection of research specimens during routine clinical procedures
o Ensuring high quality processing of research specimens
o Managing timely and compliant shipment of research specimens to research laboratories
* Provide information 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, and ensuring compliant completion of research activities
* 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 serious adverse events

Research Regulatory Management (20%)
* Support regulatory compliance for a large and complex portfolio of research projects
* Support the completion of required regulatory documentation
* Support regulatory staff in preparing regulatory approval applications; responding to stipulations, and ensuring IRB approval for research activities
* In collaboration with the research team, interpret study protocols and inform the development of consent forms and other participant materials 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
* Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
* Report Unanticipated Problems according to University policy

Administration (5%)
* Facilitate new project development and start-up activities
* Support quality improvement initiatives
* Facilitate Pre-award and Post-award grant administration
* Attend national and study meetings as appropriate

Education (5%)
* Support the training and mentoring of CRCs within the program and across the Department of Pediatrics
* Educate University faculty and staff of our regulatory and research obligations in relation to our clinical research activities
* Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care

All required qualifications must be documented on application materials

Required Qualifications
* BA/BS in a scientific or health related field and 2 years of experience in a medical setting, OR a combination of education and experience in clinical research to equal to 6 years
* Experience with computerized data management; ability to identify data for abstraction
* Computer proficiency and ability to navigate multiple software applications.
* Detail-oriented with exceptional organizational, planning and problem-solving skills
* Ability to work independently, as a part of a team and with changing priorities
* Demonstrated ability to maintain deadlines and prioritize assignments
* Excellent written, verbal and interpersonal skills
* Ability to work flexible work hours, including 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
* Research certification, such as CCRP or CCRC
* Experience with social-behavioral research
* Experience with Epic electronic medical record system
* Experience with pediatric populations

Program/Unit Description
At University of Minnesota Department of Pediatrics, ourexperts, care teamsand researchers are illuminating cures and advocating for changes that save young lives. Our ground-breaking treatments and programs are improving the lives of children who are ill or injured, and are becoming the standards 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) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.

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.

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 or call .

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:

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.

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).

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.