MD Anderson Cancer Center Human Research Regs Specialist in Houston, Texas
Human Research Regs Specialist
Location: United States, Texas, Houston, Houston (TX Med Ctr) at https://mdanderson.referrals.selectminds.com/jobs/4971/other-jobs-matching/location-only
Managerial/Professional at https://mdanderson.referrals.selectminds.com/landingpages/managerialprofessional-opportunities-at-md-anderson-cancer-center-11
VP Clinical Research 201300
Requisition #: 109391
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2015 rankings. It is one of only 45 comprehensive cancer centers designated by the National Cancer Institute.
Salary range: min-$45,500 mid-$64,000 max-$82,000
Overview NCI Clinical Trials Reporting Program Trial Registration Site (CTRP Registration Site) updates and amendments using its tools and resources to search for and view details of existing clinical trials. Additionally submitting new clinical trials and amending and/or updating those currently registered and verified in the CTRP.
To provide support, guidance, data management, and leadership for the clinical research faculty with clinical trial information registration in compliance with federal regulations. Satisfy expanding federal reporting requirements by accessing relevant clinical trial data, verifying field entries and amending data inputs routinely. Achieve amendments, updates and status changes to protocol registrations in the databases (specifically the NCI’s CTRP) according to varying timelines. Documentation to be submitted with amendments, updates, or status changes to include patient accrual reporting and elements of outcome reporting, including toxicity and adverse event reporting.
Analyzes research applications received by Protocol Research for regulatory compliance, and recommends appropriate revisions. Ensures proper administrative handling of the research application and timely submission to the appropriate agency. Prepares and maintains documentation on administrative flow of MDACC research applications. Cleans, obtains and maintains data. Creates complex reports for use in reviewing specific application information and general trends. Collects metrics and participates in department quality assurance. Develops recommendations on operations and processes. May design and provide education training sessions for faculty, draft institutional communications and/or act as a coach and team leader.
Registration, update and amend protocol records within NIH Clinical Trials Registry (ClinicalTrials.gov Protocol Registration and Results System (PRS) Registration Site) and NCI Clinical Trials Reporting Program (CTRP Registration Site).
Analyzes research applications received by Protocol Research for appropriate clinical trial registration.
Support Help Desk
Training and Education
Provide support, guidance, data management, and instruction for the clinical research faculty with clinical trial information for registration in compliance with federal regulations for each database. (Helpdesk function)
Registration & Record Maintenance
- Register, update or amend applicable clinical research registration (i.e. protocol) records for two federal registry databases:
o NIH's ClinicalTrials.gov and
o NCI's Clinical Trials Reporting Program
- Submitting new clinical trials for registration using information located in multiple MDA resources/systems, i.e. databases like PDMS, CORe, PDOL, and others.
Update and amend registration records using registry system site tools and MDA resources to search for and view details of existing clinical trials.
Amendment submissions including all changes to clinical trial (including any updates) since last submission.
Complete updates that include other changes to protocol that do not substantively affect the scientific conduct of the study, the study design, and/or the sites in which patients are being enrolled on the trial.
Achieve amendments, updates and status changes to protocol registrations in the databases according to varying federal timelines.
Collect, review and include protocol documentation to be submitted with amendments, updates, or status changes including patient accrual reporting and elements of outcome reporting, including toxicity and adverse event reporting as needed.
Manage accrual entries on CTRP Accrual database.
Assist with completion of results entries on ClinicalTrials.gov.
Required: High school diploma or equivalent.
Required: Five years related experience, with specific experience in supporting administrative or research projects. May substitute equivalent years of preferred education for required 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