Rsch Pro -Clin Rsch Coord-RN

About the Job

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.

• 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

• 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

• 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.

• Lead / participate in Pediatric Clinical Research Services initiatives (work groups, 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…