University of Minnesota Twin Cities
Clinical Research Nurse Coordinator, Level II
University of Minnesota Twin Cities, Minneapolis, Minnesota, United States, 55400
The primary purpose of this position is to support a variety of research projects and portfolios in the Department of Pediatrics, including endocrine clinical trials, and collaborating institutions according to regulatory requirements, institutional guidelines, and sponsor expectations. This position will also support clinical trials in other pediatric specialties requiring nursing expertise, as needed. Duties include performing patient assessments, administration of investigational agents, coordinating and acquisition of research samples, coordinating the enrollment of eligible patients, initiating new trials, extracting and reporting quality patient data, and responding to data queries. This position reports to the nurse supervisor, but is accountable to the program leaders, the physician-investigators, and other members of the clinical research team. This position requires some flexibility regarding days & hours worked, which can be discussed based on research portfolio need.
Research Evaluations/Data Management (75%)
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.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.Education (10%)
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.Regulatory (10%)
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.Administration (5%)
Participate in Pediatric Clinical Research Services initiatives (workgroups, process improvement, quality assurance).Attend national meetings as appropriate.Essential EmployeesThe 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.Location:
Hybrid - Minneapolis West Bank CampusAll required qualifications must be documented on application materialsRequired Qualifications:
BS degree in Nursing with at least 2 years of experience or a combination of related education and work experience to equal six years.Associate or Bachelor’s Degree in Nursing with current licensure to practice as an RN in the State of Minnesota.Clinical/Bedside nursing experience within the last 2 years.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.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.Pediatric specific clinical/bedside experience.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.
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Research Evaluations/Data Management (75%)
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.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.Education (10%)
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.Regulatory (10%)
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.Administration (5%)
Participate in Pediatric Clinical Research Services initiatives (workgroups, process improvement, quality assurance).Attend national meetings as appropriate.Essential EmployeesThe 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.Location:
Hybrid - Minneapolis West Bank CampusAll required qualifications must be documented on application materialsRequired Qualifications:
BS degree in Nursing with at least 2 years of experience or a combination of related education and work experience to equal six years.Associate or Bachelor’s Degree in Nursing with current licensure to practice as an RN in the State of Minnesota.Clinical/Bedside nursing experience within the last 2 years.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.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.Pediatric specific clinical/bedside experience.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.
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