Job Information

University of Utah BMIC Clinical Data Integration Coordinator in Salt Lake City, Utah

Open Date 09/03/2021

Requisition Number PRN27574B

Job Title Clinical Data Manager III

Working Title BMIC Clinical Data Integration Coordinator

Job Grade G

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Ability to telecommute if approved by Supervisor.

VP Area U of U Health - Academics

Department 01271 - Biomed Informatics Core CCTS

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $70,000 to $85,000

Close Date

Open Until Filled No

Job Summary

The Biomedical Informatics Core ( BMIC ) of the Clinical and Translational Sciences Institute ( CTSI ) is hiring a Clinical Data Integration Coordinator to facilitate the implementation and compliance efforts for integration of clinical data from electronic health records to follow compliance requirements for studies and projects requiring data integration from clinical sources.

The Clinical and Translational Science Institute ( CTSI ) serves as an academic home for clinical and translational research, developing innovative health services and training a new generation of investigators. Four foundations of discovery compose the institute: Cores and Services, Education and Training, Clinical Research Support Office, and Administration, and these foundations provide support for T1 to T4 research.

Utah CTSI has produced leading investigators with several NIH grants awarded for their various “bench-to-bedside” areas of research and partners with other flagship institutions to contribute published works and clinical success.

Learn more about the CTSI : https://ctsi.utah.edu/administration/about-us

Responsibilities

Works with the BMIC to implement and review clinical study design using BMIC supported tools. Reviews and manages implementation of studies for best practices and compliance for integration with clinical research systems and electronic medical record systems.

One of the key projects this position will facilitate is the implementation of REDCap and Epic service integration including compliance oversight and procedural management of study design. Ensures that the CTSI implementation of projects within the REDCap ecosystem meet regulatory requirements for integration with the University of Utah medical record system. The Clinical Data Integration Coordinator will oversee the compliance management of studies implemented, coordinate change management of the CTSI REDCap systems and implement best practices for standard operating procedures.

Specifically, this position will work directly with investigator study teams, the Biomedical Informatics Core and compliance entities of the University of Utah to maintain and ensure accurate implementation of data forms configured for synchronization or import of clinical data.

Additionally, this position will help author and maintain standard operating procedures, knowledge articles and with manage compliance review processes for reporting or audit purposes. Implementation testing and documentation review for continued compliance will also be needed.

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 five or more years of relevant clinical data management experience. Possess in-depth understanding of the conduct and regulations involving clinical trials, clinical data management, and clinical data systems, such as Federal ( FDA ) regulations and requirements governing the conduct of clinical trials including, but not limited to, GCP and ICH requirements. Possess in-depth knowledge and understanding of all data management systems and data handling procedures. Demonstrated ability to independently perform all data management activities associated with a clinical trial with minimal oversight and a high degree of quality. Possess all skills, knowledge and competencies required of the CDM I, and CDM II positions.

Preferences

· 2-5 years of REDCap experience or similar electronic data capture tool, including the design of REDCap Projects/Surveys and experience with REDCap operational management

· Experience working with participant recruitment, study data management, and/or survey data collection

· Experience with or previous training in Good Clinical Practice or Clinical Research Coordination

· Experience working with IRB guidance, compliance regulations such as HIPAA or FDA 21 CFR Part 11.

· Masters in health sciences or informatics related field preferred. 5+ years of related data collection and management experience.

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.