Our pediatric endocrinologists treat a diverse range of disorders affecting the endocrine system, including growth, puberty, the thyroid and other hormones. Clinical research in pediatric endocrinology ranges from rare disease registries to investigational drug trials.
The Clinical Research Services Program provides expert research support to investigators conducting clinical research in children. The program provides comprehensive research coordination, regulatory management, and data management.
Responsibilities Research Evaluations/Data Management (75%)
Coordinate multiple clinical research projects as assigned
Utilize the nursing process and standards to perform protocol-specific research activities, including obtaining informed consent, conducting medical procedures, monitoring adverse events, etc
Administer medications and/or treatments as defined by the study protocols
Coordinate research subject’s recruitment, screening, enrollment, ongoing participation, follow-up, etc for assigned clinical research projects
Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue.
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.
Provide effective back-up support to other members of the research team, which includes understanding the research portfolio of the whole team
Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
Act as a liaison between Investigators, University departments, outside sponsors, clinical partners, collaborators, and affiliates.
Facilitate study start-up activities. This may include: reviewing protocol materials, planning specimen collection and processing, estimating needed effort, drafting order sets, informing the development of the study budget, source documents, etc.
Attends national meetings as appropriate
Assist Clinical Research Coordinator with regulatory processes as needed. This may include: informing the study start-up process, informing the development of regulatory submissions & documents, providing back-up regulatory support, etc.
Understand the regulatory process to ensure trials are available for subject enrollment.
Participate in quality control and internal monitoring activities
Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
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.
***All required qualifications must be documented on application materials***
BS degree in Nursing with at least 2 years of clinical experience, OR Associate’s Degree in Nursing and a BA/BS in another field with at least 2 years of clinical experience, OR a combination of related education and work experience to equal six years
Current licensure to practice as a Registered Nurse in the State of Minnesota
Experience in a pediatrics, preferably pediatric endocrinology
Experience with patient care / contact, in a pediatric, or other acute medical setting
Experience with computerized data management in a healthcare setting, including electronic medical records
Computer proficiency and ability to navigate multiple software applications.
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.
Familiarity with clinical research and/or research methodology and regulations
Ability to perform venipuncture and blood collection and processing
Experience with Epic electronic medical record system
Internal Number: 337152
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.