|Job type||Full Time|
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.
•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.
•Facilitate new project development and start-up activities
•Support quality improvement initiatives
•Attends national 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
•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
•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.
About the Department
The Division of Pediatric Hematology/Oncology supports a comprehensive clinical, research and education program with a focus on five core areas: benign hematology, leukemia, brain tumors, solid tumors (sarcomas) and childhood cancer survivorship. We offer clinical trials and innovative therapy programs to ensure the best possible outcomes for pediatric cancer patients. Our investigators have earned national and international recognition for leading-edge cancer research and comprehensive care.
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|