Job Information

University of Utah Data Manager in Salt Lake City, Utah

Open Date 09/07/2021

Requisition Number PRN27567B

Job Title PS Clinical Site Monitor

Working Title Data Manager

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 President

Department 01345 - HCI Clinical Resrch Compliance

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 70000

Close Date

Open Until Filled Yes

Job Summary

The Research Compliance Office Data Manager will ensure data for oncology clinical trials is accurate, complete and entered in a timely manner, so that data generated for publication is valid, high-quality, reliable, and statistically sound. This position will work closely with numerous members of the clinical research team including the Principal Investigator (PI), Biostatistician, and Protocol Writer. This position will be responsible for developing, validating, amending, and analyzing electronic case report forms (eCRF) in accordance with the investigator-initiated trial ( IIT ) protocol and data management plan. This position will also report on the study progress as it relates to IIT data to the Data Safety Monitoring Committee. The primary focus of this position will be to ensure accurate case histories are maintained with respect to the primary and secondary data.

Huntsman Cancer Institute ( HCI ) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.

Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion.

Learn more about HCI’s commitments at huntsmancancer.org/edi and/or contact HCI’s Office of Equity, Diversity, and Inclusion.

Responsibilities

· Develops the data management plan and electronic case report forms (eCRF) in accordance with the investigator-initiated trial ( IIT ) protocol and the associated statistical analysis plan with direction from the Principal Investigator (PI), Biostatistician, Research Compliance Officer and the clinical research team.

· Performs routine data validation checks of the eCRFs at the time of routine monitoring visits for all IITs.

· Tracks OnCore calendar visit completion dates to verify the accuracy and completeness of the data.

· Responsible for determining IIT data currency and ensuring it is >80%.

· Works closely with the Research Compliance Officers to resolve problematic data inconsistencies to ensure appropriate reporting to the Data Safety Monitoring Committee ( DSMC ) and regulatory agencies as necessary.

· Generates electronic queries, when appropriate, to resolve inconsistencies in data.

· Prepares for routine monitoring visits and audits by ensuring eCRF query resolution.

· Review responses to queries to ensure appropriate resolution and resolve any discrepancies

· Provide metrics and data analysis reports to the DSMC on a monthly basis.

· Review reports prepared by the Research Compliance Officer for presentation to the DSMC to ensure consistency and accuracy in the data.

· Work with the PI and statistician to create a data management plan and set data-lock dates in accordance with the protocol.

· Export, review, and validate data exports for consistency to facilitate consistent data and ensure data captured follows the requirements outlined in the protocol.

· Review data for formatting and any missing data points. Organize the data based on the recommendations from the PI and statistician.

· Coordinate and act as a point of contact for data management questions on multiple IIT projects.

· Tracks IIT protocol amendments to ensure eCFRs are updated as appropriate to facilitate protocol compliance. Amends eCRFs as necessary for quality control purposes and business system upgrades.

· Perform quality assurance reviews for data on Industry Sponsored trials and National Cancer Trials Network studies as needed.

· Assist in the development, implementation and optimization of data collection systems and other strategies that enhance data quality and completeness.

· As needed, manage the creation of clinical research reporting documents such as manuscripts, posters or oral presentations to present data objectively in a clear, concise format.

· Responsible for ensuring compliance with results reporting for clinicaltrials.gov

· Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.

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.

Minimum Qualifications

Bachelor’s degree in a health science or related field or equivalency; and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human subjects research. Must have a working knowledge of FDA , ICH , and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

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 include credentialing as a Certified Clinical Research Associate ( CCRA ), Certified Clinical Research Coordinator ( CCRC ), and/or Certified Clinical Research Professional ( CCRP ). Prior experience as an industry CRA or Monitor is also preferred.

Hiring department may require certification by an appropriate certifying body within two years of hire.

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

Preferences

· Minimum 3 years of relevant data management experience.

· Certified Clinical Research Professional ( CCRP , CCRC , or CCRA ).

· Oncology clinical trial experience preferred.

· Working knowledge of Food and Drug Administration ( FDA ) requirements, Office of Human Research Protection ( OHRP ), International Conference of Humanization ( ICH ) Good Clinical Practice ( GCP ), as well as state and federal guidelines.

· Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.

· Strong attention to detail, establishing priorities, and adhering to deadlines.

· Able to work independently, and complete tasks to meet deadlines.

· Excellent communication skills.

Bachelor’s degree in Health Care Administration, Science, Business Administration or a related field plus five years regulatory or clinical trials experience. Knowledge Federal and International Guidelines ( CFR and ICH ). Proficient with word processing, spreadsheet and related computer applications; demonstrated human relations and effective communication skills also highly 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.