Pediatric Clinical Research Nurse

About the Job

The primary purpose of this positive is to support pediatric diabetes clinical research according to regulatory requirements, institutional guidelines, and sponsor expectations. 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 team's project manager, but is also accountable to the program leaders, the physician-investigators and members of the clinical research team.

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

Responsibilities:

• 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
• Coordinate 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
• Screen and recruit potential research participants
• Perform non-invasive and invasive protocol procedures
• Collect, ship, and process biological specimens
• Create and maintain source documentation
• 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 timely review and reporting of adverse reactions and severe adverse events
• Coordinate and attend off-site recruitment events

• Review of clinical research protocols, 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.

• Work with project manager to assist in developing budgets and start up procedures
• Support quality improvement initiatives
• Attend national and study meetings as appropriate
• Participate in CRC continuing education and provide development opportunities
• Educate University faculty and staff of our obligations in relation to our clinical research activities
• Communication with clinical teams to foster an environment of qualify research participation within the context of exceptional clinical care

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 documented on application materials

Required Qualifications:

• Current licensure to practice as an RN…