The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees, and the public.Provide guidance and expertise for the Clinical Research Systems under the Office of Clinical Research Services (CRS) for the Office of Clinical Research Administration (OCRA). Responsibilities include support of the Clinical Trials.gov (CT.gov) registration regulatory requirements and the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP) to ensure that the institution remains in compliance with federal regulations. Duties also include providing support for the Clinical Registration Help Line and educational training for the clinical research systems and reporting and analytics for clinical research metrics. Serves as a liaison for the clinical research faculty to complete clinical trial registrations and results reporting in compliance with NCI CTRP (National), CT.gov (Federal), and Institutional policies. Other duties as assigned.Key FunctionsTraining and Education· Assists in defining and analyzing problems when users call with issues regarding Clinical Registrations submitted in CTRP and CT.gov, and Results reporting in CT.gov.· Facilitates training classes on how to complete Results reporting entries in Clinical Research Systems.· Schedule one on one classes for ad hoc Results reporting on CT.gov where applicable.· Develop and maintain user manuals and video tutorials for the Clinical Research System applications.Clinical Trials Reporting Program (CTRP)· Provides support and guidance for the clinical research faculty regarding clinical trial registration requirements in compliance with national regulations.· Satisfy expanding national reporting requirements by accessing relevant clinical trial data, verifying field entries, and amending data inputs routinely to ensure the accuracy of Data Table 4 (DT4) STRAP report as it pertains to the institutional CORE Grant.· Submit required documentation regarding amendments, updates, or status changes, and patient accrual reporting in the databases (specifically the NCI's CTRP) according to varying timelines.· Register clinical research trials (i.e. protocol) records for CTRP in compliance with national regulations.· Serve as liaison between the clinical research staff and the Clinical Trial Reporting Office (CTRO) with CTRP application to address queries associated with new registration submissions, amendments, updates, and verification requirements in CTRP.· Check all newly approved and activated protocols to ensure the CCSG DT4 information entered in applicable Clinical Research Systems matches the approved clinical trial information submitted in the registration process in CTRP.Clinical Trial.gov (CT.gov)· Provides support and guidance for the clinical research faculty with clinical trial information registration and results reporting in compliance with federal regulations.· Satisfy expanding federal reporting requirements by accessing relevant clinical trial data, verifying field entries, and amending data inputs routinely in CT.gov.· Submit updates and status changes to include elements of results reporting, including outcomes, toxicity, and adverse event reporting to protocol registrations in the databases (specifically the CT.gov) according to varying timelines.· Register applicable clinical trials (i.e. protocol) records for CT.gov in compliance with federal guidelines.· Serve as liaison between the clinical research staff and the Protocol Registration and Results System (PRS) with the CT.gov application to address queries associated with new registration submissions, updates, results reporting, and verification requirements.in CT.gov.· Check all newly approved and activated protocols to ensure the clinical trial and results reporting information entered in applicable Clinical Research Systems matches the approved clinical trial information submitted in the registration process in CT.gov.EducationRequired: Bachelor's degree.ExperienceRequired: Two years of clinical research experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.htmlAdditional Information
Requisition ID: 161052
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 54,500
Midpoint Salary: US Dollar (USD) 68,000
Maximum Salary : US Dollar (USD) 81,500
FLSA: exempt and not eligible for overtime pay
Fund Type: Hard
Work Location: Remote (within Texas only)
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: No
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Full-time