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UO
University of Utah
Clinical Research Coord
Career Insights for Clinical Research Associate
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What they do
A Clinical Research Associate is responsible for running clinical trials, usually for an organization undertaking pharmacological drug testing. Will ensure that trials adhere to good clinical practice guidelines for monitoring clinical trials.
$112,525 / year median in Utah
+5% projected growth
Job Description
Clinical Research Coord Job Summary The Division of Vascular Surgery at the University of Utah has an immediate opening for a Clinical research coordinator. This position desires a person with a strong background in clinical research.
This job description 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. Work Environment and Level of Frequency that may be required:
This position will:
(1) assist in facilitating the conduct of clinical research by performing research duties for Vascular Surgeon Research Investigators; (2) coordinate technical and administrative details involved in both sponsor and physician-initiated clinical research studies; and (3) assist the Principal Investigator and study team in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures; and (4) coordinate clinical trials involving the investigational use of medical devices and drugs, including studies conducted under IDE and IND requirements. Responsibilities 1. Screen and recruit participants for clinical research studies.2. Fully understand the informed consent process and obtain informed consent from eligible study participants. Document the informed consent process. Write informed consent documents under the supervision of the study investigator.3. Attend and actively participate in study team meetings. Assume leadership roles within study teams.4. Schedule study visits and coordinate related facility and equipment availability.5. Assess research protocols for clarity and participant safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor.6. Collect and document clinical research data such as medical history and demographics; Maintain research documentation including status reports, progress notes, and participant logs to help ensure safety.7. Report and track adverse events (AEs). Reports serious AEs to PI, IRB and sponsor.8. Review and manage clinical research study databases.9. Educate staff regarding study procedures. 10. Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.11. Complete, audit, correct, and relay case report forms (CRFs) to sponsor.12. Assist with negotiating study contract budget and payment terms.13. Maintain documents as required by FDA, ICH, GCP, and IRB regulatory guidelines.14. Maintain contact with IRB and prepare and submit IRB documents.15. Ensure proper collection, processing and shipment of specimens.16. Help determine personnel required to complete trial and develop the timeline for trial completion. Review study related data to assure compliance with study protocol.17. Assist with the preparation, coordination, and facilitation of sponsor monitoring visits, including responding to follow-up items and supporting timely resolution of findings.This job description 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. Work Environment and Level of Frequency that may be required: