Job Information

University of Utah Project Administrator in Salt Lake City, Utah

Details

Open Date 08/10/2022

Requisition Number PRN31814B

Job Title Project Administrator

Working Title Project Administrator

Job Grade F

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

VP Area President

Department 01345 - HCI Clinical Resrch Compliance

Location Anywhere Utah

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 90400

Close Date

Open Until Filled Yes

Job Summary

The ClinicalTrials.gov Data Manager will serve as an education and compliance expert regarding regulations and policies governing ClinicalTrials.gov. ClinicalTrials.gov is a public registry and results database of clinical studies conducted around the world. Clinical research studies must be registered and results reported according to local and federal laws and regulations including the Food and Drug Administration, National Institutes of Health, International Committee of Medical Journal Editors, and the Centers for Medicare and Medicaid Services. This position will administer the Huntsman Cancer Institute ( HCI ) ClinicalTrials.gov program, including registration, record maintenance, and reporting for Investigator-Initiated-Trials (IITs) sponsored or lead by an HCI Investigator. Under the Research Compliance Office at HCI , the person in this position will oversee and manage activities related to data on IITs at HCI in the center’s clinical trials management system (OnCore®), which in turn serves as the primary source of data for reporting to the center leadership, National Cancer Institute ( NCI ), ClinicalTrials.gov, and NCI /clinical trials reporting program ( CTRP ). This person works closely with investigators and study staff at participating institutions to ensure pertinent data is entered into OnCore in real time so that the cancer center complies with federal and all other requirements for trial registration in all applicable databases.

This position will ensure data for oncology clinical trials is accurate, complete and entered in a timely manner, so that data generated for ClinicalTrials.gov and any other 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. The ClinicalTrials.gov Data Manager may be required to report on the study progress as it relates to IIT data to the HCI Data Safety Monitoring Committee ( DSMC ). The primary focus of this position will be to ensure accurate case histories are maintained with respect to the primary and secondary data in ClinicalTrials.gov. This position is capable for remote work.

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

· Work with Investigators and determine if ClinicalTrials.gov study registration and results is required prior to study initiation.

· Ensure ClinicalTrials.gov and CTRP record maintenance compliance through addressing system inquiries, providing regular updates, and amending any changes to the study record.

· Performs routine validation checks of the data.

· Tracks OnCore calendar visit completion dates to verify the accuracy and completeness of the data and track results reporting for Clincaltrials.gov according to the timelines described in the regulations.

· Works closely with the Research Compliance Office and study staff to resolve problematic inconsistent data to ensure appropriate reporting to the HCI Data Safety Monitoring Committee ( DSMC ), clincialtrials.gov, and regulatory agencies as necessary.

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

· 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 Office, and the clinical research team.

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

· Work with the Responsible Investigator, in collaboration with the study statistician, for reviewing and approving data and results prior to releasing records in ClinicalTrials.gov.

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

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

· Attend ClinicalTrials.gov and CTRP taskforce teleconferences.

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

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 Business Administration, Accounting, or a related field, or equivalency; four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.

Preferences

· Minimum 2 years of relevant data management experience.

· Previous experience working in online Clinical Trials Management System or Electronic Data Capture System

· Strong working knowledge of electronic clinical trial data platforms such as RedCap, OnCore, etc.

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

· Oncology clinical trial experience preferred.

· Working knowledge of Food and Drug Administration ( FDA ) requirements including the FDA Amendments Act of 2007 ( FDAAA ), 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.

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.