Job Information

University of Utah Clinical Research Coord Sr. in Salt Lake City, Utah

Open Date 05/20/2021

Requisition Number PRN26203B

Job Title PS Clinical Research Coord Sr.

Working Title Clinical Research Coord Sr.

Job Grade F

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

Monday through Friday, 9:00 AM to 5:30 PM. Some weekends and after hours.

VP Area U of U Health - Academics

Department 01643 - CLINICAL TRIALS OFFICE

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $47,600 to $79,699

Close Date

Open Until Filled Yes

Job Summary

The Clinical Trials Office at the University of Utah, School of Medicine has an immediate opening for a Senior Clinical Research Coordinator to provide support to multiple divisions within the University. Coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies

The University of Utah offers a comprehensive benefits package, a wellness program, and a competitive salary commensurate with experience. Mutual respect and appreciation are highly valued within the University of Utah.

The University of Utah offers a comprehensive benefits package with excellent health care options, 14.2% retirement contributions that vest immediately, a variety of retirement plans, and generous paid leave time. Current benefits information is available at www.hr.utah.edu/benefits .

This position is considered Category I: Mandatory and required on campus or health care facilities to support on-site operations. Employees hired into this category will be required to be physically located at the Williams Building if they are healthy and without COVID -19 symptoms.

Responsibilities

1.Develop training and staff certification materials, procedures, and requirements.

2.Mentor and train new or junior research staff.

3.Implement procedures to prevent future events, including staff education and retraining.

4.Contributes to developing educational materials for research professionals regarding studies and related research issues.

5.Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Maintain records and other documentation of training.

6.Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend and implement solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.

7.Works with PI to assess administration and logistics of the study protocol, reviews inclusion and exclusion criteria, scientific, ethical, and regulatory issues; patient population, logistics and protocol compliance.

8.Works with the study team and the PI within the University and PCH to ensure efficient study start-up.

9.Organizes pre-site selection visits and site initiation visits with study monitors and implement recruitment and retention plans for each study.

10.Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.

11.Evaluate processes to identify obstacles to successful recruitment and retention of study participants.

12.Recommend and implement innovative approaches to maximize enrollment and optimize subject retention.

13.Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.

14.Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.

15.Represent the research program at meetings, national and international research consortia.

16.Prepare, submit and maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.

17.Assist the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study.

18.Determine subject population availability, develop recruitment, informed consent, and screening materials; help develop survey and study data collection instruments.

19.Coordinate approval of new study agreements and contracts; assists in the development of case report forms.

20.Develops QA/QC processes and conducts quality control activities (field/study visits, data queries).

21.Determine study visit and site/clinic workflows for studies/protocols.

22.Helps to develop standard operating procedures.

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

Bachelor’s degree in a health science or related field or equivalency; plus, 4 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.

Care is appropriate to the population served

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

- Four years of professional clinical research experience (i.e. Clinical Research Coordinator, Regulatory Coordinator, or other related research position performing advanced and complex clinical research responsibilities) is strongly preferred.

- Previous experience developing a training program as well as training materials.

- Current CCRC or equivalent certification preferred.

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.