|Job type||Full Time|
The primary purpose of this position is to support clinical research studies within pediatrics across multiple specialties. This position will primarily support clinical research in Pediatric Critical Care, but will support other programs as needed. The Clinical Research Coordinator facilitates the conduct of research according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data, -processing biological samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team.
Research Project Coordination (70%)
• Coordinate a large and complex portfolio of research projects
• Coordinate patient participation in clinical research, including:
oScreening and recruiting patients and families
o Ensuring study eligibility and enrollment
o Scheduling and conducting research visits
• Data management for multiple projects, including:
o Data collection and entry into databases
o Ensuring data quality
o Supporting the PI and Developer in database development
• Specimen management for multiple projects, including:
o Coordinating the collection of research specimens during routine clinical procedures
o Ensuring high quality processing of research specimens
o Managing timely and compliant shipment of research specimens to research laboratories
• Provide information 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, and ensuring compliant completion of research activities
• 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 serious adverse events
Research Regulatory Management (20%)
• Support regulatory compliance for a large and complex portfolio of research projects
• Support the completion of required regulatory documentation
• Support regulatory staff in preparing regulatory approval applications; responding to stipulations, and ensuring IRB approval for research activities
• In collaboration with the research team, interpret study protocols and inform the development of consent forms and other participant materials needed for each clinical research study
• Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time
• Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
• Report Unanticipated Problems according to University policy
• Facilitate new project development and start-up activities
• Support quality improvement initiatives
• Facilitate Pre-award and Post-award grant administration
• Attend national and study meetings as appropriate
• Support the training and mentoring of CRCs within the program and across the Department of 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
• BA/BS in a scientific or health related field and 2 years research experience, OR applicable advanced degree, OR a combination of education and experience in research to equal 6 years
• Experience working with patients and families, preferably within a hospital setting and/or pediatric populations
• Experience with computerized data management in a health-related setting, including electronic medical records, preferably EPIC
• Demonstrated data management skills, including data collection, data entry and quality control
• Computer proficiency and ability to navigate multiple software applications
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as well as part of a team
• Ability to adapt to changing priorities based on most critical need
• Demonstrated ability to maintain deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• Knowledge of federal regulations related to research with human subjects and protected health information
• Ability to work flexible work hours, including occasional 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.
• Relevant research certification, such as CCRP or CCRC
• Certified Medical Assistant or similar experience
• Experience recruiting subjects to research studies
• Specimen management experience including processing human samples and shipping per regulations
• Regulatory management experience including IRB submissions and regulatory binder maintenance
About the Department
At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standard of care for children across the country and around the world.
The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.
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 email@example.com 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|