Research Coordination-Clinical Interventional/Therapeutic

The primary purpose of this position is to support clinical studies, including clinical trials, within multiple pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, performing regulatory management, and responding to data queries.

Responsibilities:
Clinical Research Project Coordination (70%)

• Coordinate patient participation in clinical research, including screening and recruiting patients and families, ensuring study eligibility and enrollment, scheduling and conducting research visits
• Data collection and submission for multiple projects, including engaging with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
• 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
• Facilitate the timely review and reporting of adverse reactions and serious adverse events
• Contribute to the production of research publications or presentations of research data
• Additional study-related activities, as assigned.

Regulatory (20%)

• Prepare regulatory submissions in collaboration with the PI including continuing reviews, protocol amendments, and consent form modifications
• Support the maintenance of 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 and Education (10%)

• Support new project development and study start-up activities
• Support quality improvement initiatives
• Serve as mentor and share knowledge with other study coordinators and study team members
• Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
• Attends local and national study meetings as appropriate

Essential Employees

The successful candidate will be 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.

All required qualifications must be included in the application materials

Required Qualifications:

• BA/BS in a scientific or health related field and 2 years research experience OR a combination of education and experience in research to equal 6 years
• Experience as a research coordinator in clinical research, including obtaining informed consent
• Working knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research
• Experience with computerized data management, preferably in a health-related setting and including experience with electronic medical records
• 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
• 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:

• Experience with computerized data management, preferably in a health-related setting and including experience with electronic medical records
• Demonstrated data management skills, including data collection, data entry, and ensuring data quality
• Specimen management experience including processing human samples and shipping per regulations
• Regulatory management experience including IRB submissions and regulatory binder maintenance

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 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.

Pay Range: $58,000 - $68,000/year; depending on education/qualifications/experience

Time Appointment: 75%-100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• The University 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

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.

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

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).

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.