Details

Open Date 06/15/2022

Requisition Number PRN31001B

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, 8:00 am – 5:00 pm.

VP Area U of U Health - Academics

Department 00991 - Pediatric Hospital Medicine

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

Job Summary

The Division of Pediatric Hospital Medicine at the University of Utah, School of Medicine has an immediate opening for a Senior Clinical Research Coordinator.

This position oversees the research functions and infrastructure of the Division of Pediatric Hospital Medicine in collaboration with the Division Manager and Division Chief. The incumbent will assist in the organization, support, management, and coordination of technical and administrative details for the clinical research mission within the division.

The University of Utah offers a comprehensive benefits package including:

• Excellenthealth care coverage (https://www.hr.utah.edu/forms/lib/SummaryComparisonEmployeeHCP.pdf) at affordable rates
• 14.2% retirement contributions (https://www.hr.utah.edu/benefits/retire\_401aPlan.php) that vest immediately
• Generouspaid leave time (https://www.hr.utah.edu/benefits/paidLeave.php)
• 10 paid Holidays per year
• 50% tuition reduction (https://www.hr.utah.edu/benefits/tuition.php) for employee, spouse, and dependent children
• Flex spending accounts (https://www.hr.utah.edu/benefits/fsa.php)
• Free transit on most UTA services
• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
• Professional development opportunities

Additional benefits information is available at www.hr.utah.edu/benefits

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. Collaborates with division manager to monitor study expenditures, assists with budget preparation for future studies, and ensures appropriate expenditure of funds.
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. 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.
11. Helps develop applicable data management queries and oversees data cleaning activities.
12. Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments
13. 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.
14. Coordinate approval of new study agreements and contracts; assists in the development of case report forms.
15. Develops QA/QC processes and conduct quality control activities (field/study visits, data queries).
16. Determine study visit and site/clinic work flows for studies/protocols.
17. Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs.
18. Helps to develop standard operating procedures.
19. Prepares reports for internal and external customers, including division chief and manager, project investigators, study sponsors and collaborating institutions.
20. Compiles information for grant applications.
21. Participates in abstract and manuscript preparation.
22. Performs other necessary research support functions as assigned by PI, manager or division chief.

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.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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

Department Specific Preferences

• Experience with clinical research, including research protocols, procedures, data collection, IRB oversight, multi-site collaboration, and budget management.
• Demonstrated administrative experience in organizing and coordinating multiple projects running simultaneously.
• Ability to communicate and work effectively with medical, administrative, and research personnel at all levels.
• Team Player – demonstrates enthusiasm, positive attitude, integrity, and commitment to the research mission by helping with special projects and working as directed and where needed.
• Critical thinking skills – ability to analyze data, draw conclusions and make recommendations to superiors.
• Superior organizational skills – experience managing multiple projects simultaneously, ability to independently and correctly prioritize tasks, excel at time management, and demonstrate capacity to present information professionally and concisely.

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.