|Job type||Full Time|
• Main coordinator for the ASTOR Registry, including oversight of all registry activities
• Participate in developing and implementing strategies for increasing recruitment to the ASTOR registry in collaboration with sponsors and investigators
• Coordinate participant recruitment and screening for available trials and studies.
• Ensure subject eligibility and coordinate subject enrollments and informed consent processes
• Coordinate subject visits, ensuring the appropriate recording of adverse events, and timely acquisition of research tissues.
• Coordinates effective specimen management, including preparing kits, processing specimens, preparing shipments, tracking inventory, etc.
• Coordinates 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.
• Coordinate the timely review and reporting of adverse reactions and severe adverse events
• Facilitate Interim Monitoring Visits, as well as resolving all action items resulting from the visit.
• Serve as primary contact to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
• Contribute to the production of research publications or presentations of research data
Regulatory Management (25%)
• Support regulatory management of the ASTOR Registry
• Implement and oversee electronic consent for the ASTOR registry
• Support the regulatory requirements and processes for assigned research studies, including applications, consent forms, etc. Track regulatory review submissions to ensure deadlines are met.
• Maintain complete and compliant regulatory binders and required documentation for each clinical research study. Ensure study materials are audit-ready at any given time.
• Coordinate initiation visits, monitoring visits, program audits, etc.
• Report Unanticipated Problems according to University policy
Study Activation (15%)
• Support study start-up activities and ensuring project progresses through the required processes and approvals
• In collaboration with the PI, interpret study protocols and develop consent form documents needed for each clinical research study
• Support initial IRB and other regulatory approvals, including required pre-reviews
• Support contract and budget development and negotiation workflows
• Support marketing initiatives for the ASTOR registry
• Support new project development
• Support quality improvement initiatives
• Attends national and study meetings as appropriate
• Training of CRCs within the program and across Pediatrics
• Educate University faculty and staff 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
All required qualifications must be documented on application materials
• BA/BS in a scientific or health related field and at least 2 years of experience, OR a combination of education and experience in clinical research to equal to 6 years
• Experience with computerized data management; 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
• Experience with Epic or other electronic medical record system
• Experience with patient care / contact
• 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.
• Research certification, such as CCRC or CCRP
• Clinical research experience at the University of Minnesota, or in Pediatrics
About the Department
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 Division of Pediatric Nephrology is dedicated to providing comprehensive care to infants, children, and adolescents with a range of kidney diseases, as well as leading innovative research. Our physician-researchers are dedicated to the study and treatment of patients with Alport Syndrome and have established the Alport Syndrome Treatments and Outcomes Registry (ASTOR) to support new clinical trials to treat this condition.
How To Apply
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.
To request an accommodation during the application process, please e-mail firstname.lastname@example.org or call (612) 624-UOHR (8647).
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.
Background Check Information
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
|Employer||University of Minnesota|