Job Information

University of Utah Research Data Coordinator in Salt Lake City, Utah

Open Date 03/17/2021

Requisition Number PRN25570B

Job Title PS Clinical Data Manager II

Working Title Research Data Coordinator

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

VP Area President

Department 01167 - HCI Clinical Trials Operations

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39300 to 48000

Close Date

Open Until Filled Yes

Job Summary

This position is primarily a study lead Clinical Data Manager. It supports multiple clinical study teams by reviewing and/or completing study related clinical data management deliverables. Frequently interacts with study team members to troubleshoot, manage, and develop study specific processes. Actively participates in the development of processes, and documents, that support the clinical data management team.

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

1.Participate in the cross-functional project teams as the lead clinical data manager.

2.Provide input in the design of protocols, forms, and data collection processes.

3.Create and maintain the following study specific documents:

•Data Management Plans

•Edit specifications

• SAE Reconciliation Guidelines

•Other plans and guidelines as required

4.Ensure documents are provided according to established timelines and SOPs.

5.Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.

6.Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.

7.Review and provide feedback on other study specific documents.

8.Manage all data management activities of a clinical trial in the maintenance phase of the project.

9.Provide project specific training on electronic data capture ( EDC ) and other data management systems to internal and external personnel.

Problem Solving

Employees in this position are required to discuss questions and suggestion for improvements with the study team prior

to implementing new or modified study specific processes. The Clinical Data Manager II is expected to have a solid

understanding of the regulatory framework as it relates to clinical research and data management, and be able to

assess current and proposed processes for compliance with regulations and standards.

Comments

This position is intended to be focused on study level activities with oversight from the manager of clinical data

management. Employees are expected to be the independent representative of the clinical data management function

on the cross functional study team.

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 typically required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelor’s degree in the life sciences, pharmacy, nursing, a related subject, or equivalency. Requires two or more years of relevant clinical data management experience. Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems. Ability to perform all data management activities associated with a clinical trial with a high degree of quality. Possess all skills, knowledge and competencies required of the CDM I position.

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.

Preferences

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.