Research - Laboratory/Non-Laboratory, Staff/Administrative
Our program seeks a Clinical Research Coordinator, Level I, who will be responsible for the coordination and data management of assigned clinical research studies. Persons in a CRC I position in this division will primarily be assigned to the Children’s Oncology Group Registry – Project: Every Child. This international registry of infants, children, adolescents, and young adults with cancer supports current and future therapeutic clinical trials and the discovery efforts that will lead to more effective therapies, prevention, earlier detection and reductions in early and late effects of treatment. This position will also support other research studies/trials and partner with other team members to meet project goals and outcomes. Duties include coordinating the enrollment of eligible patients, extracting and reporting quality patient data, and responding to data queries. This position reports to the Clinical Research Program Director, but is accountable to the program leaders, the physician-investigators, and members of the research team.
Major Duties/Job Description:
Clinical Research Conduct & Facilitation (80%) •Coordinate study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits •Act as 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 collection and submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts. •Process human specimens per protocol requirements, coordinate shipping as needed •Facilitate the timely review and reporting of adverse reactions and severe adverse events •Conduct data abstraction for chart review studies
Regulatory (10%) •Partner with Regulatory Specialist, the PI and study team to ensure ethical conduct of clinical trials •Provide documentation and reports related to study participation (adverse event reports, protocol deviations, etc.) to the regulatory 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 studies
Education & Administration (10%) •Attends national conferences and study meetings as appropriate •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, OR a combination of education and experience in research to equal to 4 years •Experience with computerized data management in a health-related setting, including electronic medical records •Demonstrated ability to identify data for abstraction •Detail-oriented with exceptional organizational, planning and problem-solving skills •Ability to work independently and as a part of a team and with changing priorities •Demonstrated ability to maintain deadlines and prioritize assignments •Excellent written, verbal and interpersonal skills •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: •Experience working in an academic medicine or pediatric acute medical setting •Knowledge of Good Clinical Practices (GCPs) and federal regulations related to clinical research •Experience with patient care / contact and recruiting patients to clinical trials •Ability to work flexible work hours, including occasional evening and weekends
Internal Number: 341952
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.