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 preparing for initiation of new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. 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 lower acuity Phase III studies, database and registry studies, cancer control studies and/or long-term follow-up studies.
Responsibilities 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 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. • 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 • Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. • Ensure work is conducted in compliance with federal regulations, GCPs, and University and M Health policies related to research
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. • Lead the preparation 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%) • Support the 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 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 • 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 • 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 • 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 • Certification as a CCRP or CCRC or willingness to become certified. • Experience with computerized data management at UMMCH, including electronic medical records (Epic) • Certified Medical Assistant or similar experience • Experience with pediatric populations • Ability to work flexible work hours, including occasional evening and weekends.
Internal Number: 336333
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.