Pediatric Clinical Research Coordinator - Drive Trials

Job Summary The Department of Pediatrics, Division of Medical Genetics at the University of Utah School of Medicine has an immediate opening for a Clinical Research Coordinator. The Clinical Research Coordinator will coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care. Create and maintain tools and documentation to track study metrics, providing updates to management. Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities. Maintain source documents and report adverse events. Recruit, screen, enroll, and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies. Work under the direction of the Primary Investigator (PI). Department Summary The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: Mutual respect and appreciation are highly valued in the department. Employee Health Requirements This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Responsibilities Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care. Create and maintain tools and documentation to track study metrics, providing updates to management. Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities. Maintain source documents and report adverse events. Recruit, screen, enroll, and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies. Work under the direction of the Primary Investigator (PI). Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor. Completes, audits, corrects CRFs, relays CRFs to sponsor. Maintains documents as required by FDA guidelines. Ensures proper collection, processing and shipment of specimens. Clinical Research Coordinator (Non-R.N.), I Requires basic skill set and proficiency. Conduct work assignments as directed. Closely supervised with little latitude for independent judgment. Requires a bachelor’s (or equivalency) + 2 years of directly related work experience or a master’s (or equivalency) degree. This is an Entry‑Level position in the General Professional track. Job Code: PZ6511 Grade: P11 Expected Pay Range: $18.51 to $25.15 Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience). Clinical Research Coordinator (Non-R.N.), I: Requires a bachelor’s (or equivalency) + 2 years of directly related work experience or a master’s (or equivalency) degree. Preferences Prior clinical research experience preferred. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; attention to detail; and the ability to function independently. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs. This position may require the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Equal Opportunity Statement Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy‑related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX (OEO). For more information, please refer to the University of Utah Non‑Discrimination page. #J-18808-Ljbffr