Research Coordination (50%) • Lead coordinator for the ASTOR Registry, including oversight of all registry activities • Develop and implement strategies for increasing recruitment to the ASTOR registry in collaboration with sponsors and investigators • Independently coordinate participant recruitment and screening for available trials and studies. • Ensure subject eligibility and compliant subject enrollments and informed consent processes • Manage subject visits, ensuring the appropriate recording of adverse events, and timely acquisition of research tissues. • Ensure effective specimen management, including preparing kits, processing specimens, preparing shipments, tracking inventory, etc. • 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. • 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%) • Manage all regulatory aspects of the ASTOR Registry • Implement and oversee electronic consent for the ASTOR registry • Manage 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. • Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations • Coordinate initiation visits, monitoring visits, program audits, etc. • Report Unanticipated Problems according to University policy
Study Activation (15%) • Manage 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
Administration (5%) • Support marketing initiatives for the ASTOR registry • Support new project development • Support quality improvement initiatives • Attends national and study meetings as appropriate
Education (5%) • Training and mentoring 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
Required Qualifications: • BA/BS in a scientific or health related field and at least 4 years of experience, OR a combination of education and experience in clinical research to equal to 8 years * Experience coordinating clinical trials • 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.
Preferred Qualifications: Research certification, such as CCRC or CCRP • Clinical research experience at the University of Minnesota, or in Pediatrics
Internal Number: 340788
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.