The primary purpose of this position is to support a variety of clinical research projects and portfolios within the Department of Pediatrics, including endocrine clinical trials and studies conducted in collaboration with partnering institutions, in accordance with regulatory requirements, institutional policies, and sponsor expectations. This position may also provide support for clinical trials across other pediatric specialties requiring nursing expertise, as needed.

Responsibilities include conducting participant assessments, administering investigational products and study-related procedures, coordinating and collecting research specimens, facilitating participant recruitment and enrollment, supporting study start-up activities, extracting and reporting study data, responding to data queries, and ensuring protocol compliance throughout the conduct of clinical research studies.

This position reports to the Nurse Supervisor and works collaboratively with physician-investigators, program leaders, sponsors, and other members of the clinical research team.

The position is primarily Monday through Friday, daytime hours. Flexibility in work hours may be required to accommodate early morning study visits, participant schedules, and research protocol requirements.

Responsibilities:

Research Evaluations/Data Management (70%)

• Lead consent and assent conversations with participants and families ensuring they understand what the research involves and how it differs from clinical care
• Maintain open lines of communication with participants and families regarding research assessments; focus on providing education and transparency.
• Utilize the nursing process and standards to safely perform protocol-specific procedures
• Administer medications and/or treatments as defined by the study protocol
• Research order entry in Epic, according to protocol
• Manage research subject's participation ensuring all protocol assessments are completed
• Act as information resource to University of Minnesota faculty and staff for protocol specific questions, including availability of trials, enrollment requirements, assessments, 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 samples
• Ensure timely and accurate data submission, engage with providers and investigators to ensure adequate source documentation is available with accurate interpretation and recording of data

Education & Leadership (20%)

• Meet participants/families where they are in regard to educational needs. Provide education as appropriate.
• Educate University faculty and staff of our regulatory and research obligations in relation to program research activities
• Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
• Contribute to the education of other research coordinators through training new staff, participating in mentoring opportunities, and engagement with the University clinical research community
• Present educational topics at staff meetings
• Serve as source of support to research team (leadership, regulatory and coordinators) and provide oversight when on the unit or in the clinic to coordinators to ensure participant and staff safety

Regulatory (5%)

• Review of clinical research protocols to ensure feasibility and success, review subject consent forms and other study documents, ensuring understandability
• Understanding of the regulatory process to ensure participant safety
• Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.

Administration (5%)

• Lead / participate in Pediatric Clinical Research Services initiatives (workgroups, process improvement, quality assurance)
• Attend national 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.

Qualifications

All required qualifications must be documented on application materials

Required Qualifications:

• Bachelor's Degree in Nursing plus at least 4 years of relevant experience, or advanced degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least eight years.
• Current licensure to practice as an RN in the State of Minnesota
• Clinical/Bedside nursing experience in Pediatrics within the last year
• Prior exposure to research in Pediatrics setting
• 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:

• Ability to prioritize patient safety, adjust to change and escalate appropriately
• Ability to work effectively with all members in the healthcare setting
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Computer proficiency and ability to navigate multiple software applications
• Demonstrated ability to meet deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• Experience working with Epic (electronic medical record system)
• Awareness of clinical research purpose, regulations, methodologies and/or clinical trial coordination
• Experience with investigational drugs and/or devices

About the Department

At the University of Minnesota in the Department of Pediatrics, our experts, care teams and 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 supports a variety of research projects and portfolios in the Department of Pediatrics. This includes supporting research in the Endocrinology Division. Our pediatric endocrinologists treat a diverse range of disorders affecting the endocrine system, including growth, puberty, the thyroid and other hormones.

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 and Benefits

Pay Range: $84,302.40 - $100,526.40; depending on education/qualifications/experience

Time Appointment: 80% - 100% Appointment (Hybrid)

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:

• 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
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.