Research Professional 3
Minneapolis, MN  / Saint Paul, MN 
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Posted 22 days ago
Job Description
Job ID
350632
Location
Twin Cities
Job Family
Research-Support
Full/Part Time
Full-Time
Regular/Temporary
Regular
Job Code
8352P3
Employee Class
Civil Service
About the Job

The primary purpose of this position is to support clinical research projects in a variety of pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, supporting research evaluations and measurements, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.

Research Project Coordination (60%)
* Support a large and complex portfolio of research projects across multiple therapeutic areas that have complex operational logistics, including multi-site, multi-location trials that require advanced coordination skills
* Coordinate patient participation in clinical research, including: Screening and recruiting patients and families, Ensuring study eligibility and enrollment, and Scheduling and conducting research visits
* Data management for multiple projects, including: Data collection and entry into databases, Ensuring data quality, Supporting the PI and Developer in database development
* Specimen management for multiple projects, including: Facilitating the collection of research specimens during routine clinical procedures, Ensuring high quality processing of research specimens, and Coordinating timely and compliant shipment of research specimens to research laboratories
* Be a resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
* Engage with the research team 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%)
* Complete regulatory tasks as assigned
* Support the completion of required regulatory documentation
* 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 clinical research studies as assigned 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 (10%)
* Facilitate new project development and start-up activities
* Initiate and lead quality improvement projects, and contribute to departmental and program initiatives
* Ensure accurate project time tracking
* Facilitate Pre-award and Post-award grant administration
* Attends national and study meetings as appropriate

Education (10%)
* 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
* Mentor and train program junior staff as assigned

Qualifications

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

Preferred Qualifications:
*Experience working with patients and families, preferably within a hopsital setting and/or pediatric populations
*Experience with computerized data management in a health-related setting
*Demonstrated data management skills, including data collection, generating reports, and ensuring data quality
*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
*Knowledge of federal regulations related to research with human subjects and protected health information
*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.
*Advanced degree: MPH, MSW or similar
*Experience with OnCore CTMS and Epic electronic medical record system
*Experience with pediatric populations

About the Department

At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are 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) 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.

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
  • 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)
  • Financial counseling services
  • Employee Assistance Program with eight sessions of counseling at no cost

Please visit the 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-UOHR (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.

Please note: All employees at the University of Minnesota are required to comply with the University's Administrative Policy: COVID-19 Vaccination and Safety Protocol by either providing proof of being fully vaccinated on their first day of employment, or complete a request for an exemption for medical exemption or religious reasons. To learn more please visit:

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.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full or Part Time
Required Education
Bachelor's Degree
Required Experience
4+ years
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