Details
Open Date 06/03/2022
Requisition Number PRN30836B
Job Title PS Clinical Research Coord
Working Title PS Clinical Research Coord
Job Grade E
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary
weekdays
VP Area U of U Health - Academics
Department 00917 - Vascular Surgery Development
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 64349
Close Date
Open Until Filled Yes
Job Summary
The Division of Vascular Surgery at the University of Utah has an immediate opening for a research coordinator/associate. This position desires a person with a strong background in clinical research.
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.
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.
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:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils ( there is air or skin exposure to oils or other cutting fluids ).
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelors degree in a health sciences or related field 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.
Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.
This position is patient-sensitive and must fulfill all associated requirements. 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
Preferred: Master’s degree in a health science field.
Preferred: 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 )
Type Benefited Staff
Special Instructions Summary
Additional Information
The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. 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.
The University of Utah is an Affirmative Action/Equal Opportunity employer and 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 Affirmative Action:
Director/ Title IX Coordinator
Office of Equal Opportunity and Affirmative Action ( OEO /AA)
135 Park Building
Salt Lake City, UT 84112
801-581-8365
oeo@utah.edu
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
To inquire about this posting, email:employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
