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. Provides expertise in the conduct of quality clinical research to internal and external stakeholders. Impacts compliance relating to human subject research. Ensures all deliver... more details
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.
Provides expertise in the conduct of quality clinical research to internal and external stakeholders.Impacts compliance relating to human subject research.Ensures all deliverables are accurate and complete by maintaining quality control checks.Conducts quality data related initiatives to ensure data integrity is in place.Provides guidance to the department and to the clinical research community as it pertains to federal and institutional processes and standard operating procedures.
Job Specific Competencies
Clinical Content Review (CCT) - 40%
·Utilizes clinical judgment and critical thinking skills to conduct clinical content reviews to ensure the requested treatment plan/clinical tool build complies and aligns with the research study submitted to the IRB for approval.
·Ensures Clinical Content Templates are in alignment with the clinical research study submitted for IRB approval and is ready to move forward for treatment plan build.
·Aids research study teams responsible for completing the Clinical Content Template (CCT) for Epic treatment plan build by ensuring all study related drugs, test and labs are included.
·Assists with completing the CCTs for study team as needed.
·Reviews and validates the treatment medications, dosage, administration, and labs align with the research study and schedule of events in ePRTCL.
·Reviews study modifications to determine if impacts treatment plans or requires a new CCT submission.
Epic Treatment Plan Build Validation - 40%
·Determines which tests and evaluations are consistent with the standard of care and which are research related.
·Validates the beacon treatment plan by applying working knowledge of Industry Standard and Investigational drugs ensuring that all captured items, including chemotherapy, drug dosage, mode of administration, and lab tests, accurately align with the clinical research study in ePRTCL.
·Reviews record to ensure research-related evaluations and tests are conducted according to clinical research study requirements.
·Monitors new study submissions and amendments in ePRTCL to ensure studies have approval from the Institutional Review Board (IRB) for protocol build process in Epic. Communicates with study team to resolve potential treatment plan alignment issues which may cause protocol deviations and violations.
·Assess study readiness for activation by ensuring IRB and principal investigator approvals are updated in Cherwell prior to protocol migration in Epic and adhering to study activation timelines.
·Makes determinations related to the study termination process and deactivation of treatment plans, clinical content such as smart-sets related to study terminations.Processes termination requests to prevent downstream patient safety and billing impacts.
Information Resource/Liason (20%)
·Functions as a subject matter expert regarding the treatment plan build process and implementation on clinical content in Epic.Provides regulatory compliance with federal, state, and policies related to clinical research.
·Serves as a resource for the clinical research departments, central office and other ancillary teams responsible for building clinical content.
·Provides guidance, expertise and technical support related to research systems and electronic health record (EHR) system.Communicates and presents relevant findings to individuals, groups, and committees as required.Identifies quality improvement opportunities and participates in the development of quality-related initiatives. Assists with the creating and review of standard operating procedures. Helps with onboarding of new employees as needed.
Other duties as assigned
Education Required: Bachelor's degree in Business Administration or healthcare related field.
Experience Required: Five years of relevant clinical research experience. May substitute required education with years of related 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.html
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