The primary purpose of this position is to support clinical research within the CAH, DSD, genetics and metabolism program, and other pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team.
Clinical Research Conduct & Facilitation (75%)
* Support the Lead Coordinator and Research Nurse in coordinating all study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits
* Assist the study team in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research specimens.
* Support the study team to 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.
* Assist the Lead Coordinator and Research Nurse in ensuring the timely review and reporting of adverse reactions and severe adverse events
* Contribute to the production of research publications or presentations of research data
Research Regulatory Management (15%)
* Support the maintenance of regulatory binders and required documentation as directed
* Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
* Report Unanticipated Problems according to University policy
* Educate others of our regulatory and research obligations in relation to our clinical research activities
* Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
* Facilitate new project development and start-up activities
* Support quality improvement initiatives
* Attend national and study meetings as appropriate
All required qualifications must be documented on application materials
* BA/BS in a scientific or health related field, OR a combination of education and experience to equal to 4 years
* Demonstrated ability to identify data for abstraction
* 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
* Ability to work flexible work hours, including evening and weekends.
* 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.
* Knowledge of clinical research
* Knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research
* Experience with Epic or other electronic medical record system
* Experience with patient care / contact
At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments 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 Leo Fung Center for Congenital Adrenal Hyperplasia (CAH) and Disorders for Sex Development (DSD) is a multidisciplinary program committed to comprehensive care and improving outcomes. 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.
Working at the University
At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.
The University also offers a comprehensive benefits package that includes:
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Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.
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