Job Details

ID #2798669
Estado Utah
Ciudad Salt lake city
Full-time
Salario USD TBD TBD
Fuente University of Utah
Showed 2019-10-21
Fecha 2019-10-22
Fecha tope 2019-12-20
Categoría Etcétera
Crear un currículum vítae

Research Compliance Office Data Compliance Officer

Utah, Salt lake city 00000 Salt lake city USA

Vacancy caducado!

DetailsOpen Date 10/21/2019Requisition Number PRN22286BJob Title Compliance OfficerWorking Title Research Compliance Office Data Compliance OfficerJob Grade FFLSA Code AdministrativePatient Sensitive Job Code? NoStandard Hours per Week 40 hoursFull Time or Part Time? Full TimeShift DayWork Schedule SummaryM-F.VP Area PresidentDepartment 01345 - HCI Clinical Resrch ComplianceLocation CampusCity Salt Lake City, UTType of Recruitment External PostingPay Rate Range 47,600 - 66,000Close DateOpen Until Filled YesJob SummaryThe Research Compliance Office Data Manager Compliance Officer 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), Clinical Research Coordinator, Research Data Coordinator, Biostatistician, Clinical Site Monitor, Regulatory, and Protocol Writer. This position will be responsible for developing, validating, amending, and analyzing electronic case report forms (eCRF) in accordance with the protocol. This position may also report on the study progress as it relates to Investigator Initiated Trial ( 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 for oncology clinical trials at Huntsman Cancer Institute.ResponsibilitiesResponsibilities: Work with the PI and statistician to create a data management plan in accordance with the protocol. Develops IIT eCRF in accordance with the protocol and the associated statistical analysis plan with direction from the Principal Investigator (PI), Biostatistician, Clinical Site Monitor and the Clinical Trials Office research team. Assist in the development, implementation and optimization of data collection systems and other strategies that enhance data quality and completeness 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. Oversee, coordinate and conduct quality assurance reviews for Industry Sponsored and National Cancer Trials Network studies to ensure compliance with study protocol, University, state and federal guidelines. Verify the data submitted by the study sites is complete and accurate, ensuring the quality, integrity and validity of the data collected. Report quality findings to the Director of Research Compliance, the Program Manager, the Clinical Trials Office Director, and the Principal Investigator as appropriate. Generates electronic queries, when appropriate, to resolve inconsistencies in data Review responses to queries to ensure appropriate resolution and resolve any discrepancies 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 oncology clinical trials. 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. Ensure compliance with results reporting for clinicaltrials.gov Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.DisclaimerThis 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 QualificationsBachelor’s degree in Health Care Administration, Business Administration or a related field or equivalency (2 years related work experience may be substituted for 1 year of education). Five years regulatory or administrative law experience, with at least three of those years in a health care setting or equivalency; coding certification ( CPC , ACS , CCS -P/H, RHIA ); knowledge of medical auditing, Federal healthcare program policies and requirements (including Medicare Parts A and B), and ICD -10, CPT , HCPCS , DRG coding; proficient with word processing, spreadsheet and related computer applications; demonstrated human relations and effective communication skills also required.Knowledge of utilization review and quality assurance procedures is preferred. An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred.Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.Preferences- Certified Clinical Research Professional ( CCRP , CCRC , or CCRA )- Prior experience or knowledge of oncology, and oncology-related research- 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- Experience in the management of clinical trials and the clinical development process. Oncology clinical trial experience preferred.- Able to exercise appropriate judgment within generally defined practices and policies in selecting method for obtaining solutions- Able to show initiative and work independently, take initiative and complete tasks to meet deadlines- Knowledge of utilization review and quality assurance procedures is preferred. An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred.Type Benefited StaffSpecial Instructions SummaryAdditional InformationThe University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.To inquire about this posting, email: [email protected] or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: [email protected] .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.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.

Vacancy caducado!

Suscribir Reportar trabajo