MD Anderson Cancer Center Human Research Regulations Specialist - Protocol Review & Reporting in Houston, Texas

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.

The Human Research Regulations Specialist provides support, guidance, data management, and leadership for the clinical research faculty with clinical trial information registration in compliance with federal regulations.

JOB SPECIFIC COMPETENCIES

Administrative

-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:

NIH's ClinicalTrials.gov and

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.

Regulatory Documentation

-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.

Education

Required: High school diploma or equivalent.

Preferred: Bachelor's degree.

Experience

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.

Preferred: Previous research regulatory experience.

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

Additional Information

  • Employee Status: Regular

  • Minimum Salary: US Dollar (USD) 46,900

  • Midpoint Salary: US Dollar (USD) 65,700

  • Maximum Salary : US Dollar (USD) 84,500