University of Utah Health Research · 1 day ago
Clinical Research Coord
Salt Lake City, UT
Full-time
Onsite
Entry, Mid Level
$39K/yr - $73K/yr
2+ years expUniversity of Utah Health Research is seeking a Clinical Research Coordinator to assist in facilitating clinical research for Vascular Surgeon Research Investigators. The role involves coordinating technical and administrative details of research studies and ensuring the integrity and objectives of the studies are met.
Higher Education
Responsibilities
Screen and recruit participants for clinical research studies
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
Attend and actively participate in study team meetings. Assume leadership roles within study teams
Schedule study visits and coordinate related facility and equipment availability
Assess research protocols for clarity and participant safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor
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
Report and track adverse events (AEs). Reports serious AEs to PI, IRB and sponsor
Review and manage clinical research study databases
Educate staff regarding study procedures
Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor
Complete, audit, correct, and relay case report forms (CRFs) to sponsor
Assist with negotiating study contract budget and payment terms
Maintain documents as required by FDA , ICH , GCP , and IRB regulatory guidelines
Maintain contact with IRB and prepare and submit IRB documents
Ensure proper collection, processing and shipment of specimens
Help determine personnel required to complete trial and develop the timeline for trial completion. Review study related data to assure compliance with study protocol
Qualification
Required
Bachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required
Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required
This position is patient-sensitive and must fulfill all associated requirements
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description
Preferred
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred
Master's degree in a health science field
Credentialing as an Association of Clinical Research Professionals (ACRP) Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP)
Benefits
Health Insurance
Utah Retirement Systems
Company
University of Utah Health Research
At University of Utah Health, our world-class researchers work together to tackle some of the toughest problems in health and medicine.
5001-10000 employees
H1B Sponsorship
University of Utah Health Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase