Our program seeks a Clinical Research Coordinator, Level II who will be responsible for the coordination and data management of assigned Children’s Oncology Group and business and industry sponsored research studies designed to improve treatments and outcomes for children diagnosed with cancer and other blood diseases. Duties include coordinating the enrollment of eligible patients, extracting and reporting quality patient data, responding to data queries and preparing for initiation of new trials. This position must conduct work according to regulatory requirements, institutional guidelines, and sponsor expectations. Persons in a CRC II position in this division are primarily assigned to manage Phase II/III studies, database and registry studies, and/or long-term follow-up studies.
Major Duties/Job Description:
Clinical Research Conduct & Facilitation (80%) •Independently manage a large and/or complex project, or portfolio of projects. •Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. •Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and acquisition of research samples. •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. •Facilitate the timely review and reporting of adverse reactions and severe adverse events •Contribute to the production of research publications or presentations of research data •Ensure work is conducted in compliance with federal regulations, GCPs, and University and M Health policies related to research •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.
Regulatory (10%) •Partner with Regulatory Specialist, the PI and the rest of the study team to ensure ethical conduct of clinical trials. •Provide documentation and reports related to subject experience on trials (adverse event reports, subject complaints, etc.) to the research team to ensure compliance with applicable policies, procedures and regulations. •Support the Investigators in ensuring the protection of all human research participants according to Federal regulations, University policies, and sponsor expectations. •Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. for assigned trials.
Administration (5%) •Facilitate new project development and start-up activities •Support quality improvement initiatives •Attends national and study meetings as appropriate
Education (5%) •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 2 years clinical research experience or a combination of related education and work experience to equal 6 years; position involves comparing, verifying and reconciling data to help division achieve overall objectives. •Demonstrated data management skills, including data collection, generating reports, and ensuring data quality, preferably in a healthcare setting •Detail-oriented with exceptional organizational, planning and problem-solving skills •Ability to work independently, as a part of a team and with changing priorities •Specimen management skills, or willingness to learn (including processing human samples and shipping per regulations) •Demonstrated ability to maintain deadlines and prioritize assignments •Excellent written, verbal and interpersonal skills •Knowledge of Good Clinical Practices (GCPs) and federal regulations related to research with human subjects and protected health information
Preferred Qualifications: •Certification as a CCRP or CCRC or willingness to become certified. •Experience with EPIC or electronic medical records systems •Experience with pediatric populations •Ability to work flexible work hours, including occasional evening and weekends.
Internal Number: 340882
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.