Job Information

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

Open Date 06/11/2021

Requisition Number PRN26476B

Job Title PS Clinical Research Coord Sr.

Working Title PS 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

VP Area U of U Health - Academics

Department 00952 - Division of Epidemiology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

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

Close Date

Open Until Filled Yes

Job Summary

The Senior CRC will be housed in the Division of Epidemiology’s Program for Addiction Research, Clinical Care, Knowledge and Advocacy ( PARCKA ). Coordination of a complex clinical trial for substance use disorder ( SUD ). Job duties will require interaction with study participants, investigators, clinic staff, pharmacy, research staff, and study monitors. The incumbent will represent the site with weekly presentations at a national meeting, as well as act as the project leader locally. Other job duties include oversight of RAs assigned to the study, monitoring recruitment and ensuring study goals are met.

This position is considered Category IIA : Not required on campus and has the ability to telework remotely for the duration of the University of Utah’s response to COVID -19. An employee hired into this role will be responsible for providing space, telephone, printing, networking and/or internet capabilities at the telecommute location and agree to the terms of the University of Utah campus and Health Academics COVID -19 Telecommuting Agreement.

Responsibilities

Essential Functions

1.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.

2.Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor.

3.Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention.

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

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

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

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

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

9.Assist in the selection and hiring process for study staff; supervise, mentor and train new or junior research staff; provide direction and oversee preparation of study staff for monitoring visits; manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve KRONOS .

10.Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.

11.Develop training and staff certification materials, procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. 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.

12.Helps develop applicable data management queries and oversees data cleaning activities.

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

14.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.

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

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

17.Determine study visit and site/clinic work flows for studies/protocols

18.Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs

19.Helps to develop standard operating procedures

20.Compiles information for grant applications

21.Participates in abstract and manuscript preparation.

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.

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

Problem Solving

The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved. The incumbent functions independently under minimal supervision, following FDA , Good Clinical Practice, IRB , NIH , NCI , NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator as necessary.

The incumbent is expected to closely monitor use of experimental equipment and drugs. Because some subjects referred to participate on a research study have no other option for recovery, the incumbent must be aware of the subjects condition, well informed in the use of study material (devices, equipment, etc.) and conscientious in his/her analysis of appropriate actions.

The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

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.