Senior Research Data Coordinator
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 2021-2022 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
The mission of The University of Texas MD 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 administrative and patient care services for the coordination of research studies.
JOB SPECIFIC COMPETENCIES
Essential Document Maintenance for Clinical Research Conduct
Works with clinical research team to maintain essential documents (including electronic format) necessary to demonstrate compliance the Code of Federal Regulations, Good Clinical Practice Guidelines, and institutional policies. Have essential documents current and available for review by sponsors, regulatory authorities, and auditors. This will include but not be limited to completing/updating/maintaining FDA form 1572, financial disclosure forms, delegation of authority logs, physician CV/medical license/training, lab certifications and normal ranges, general research training and/or protocol training documentation, notes to file, general correspondence, sponsor correspondence, IRB correspondence.
Departmental Protocol Priority List Maintenance
Works with research administration, regulatory team, and faculty leads to update and maintain protocol priority list database including providing reports, updates, and lists for distribution in meetings and in clinical areas.
IRB submissions for Revisions/Amendments
Work with regulatory team and protocol principal investigators to assist with the submission of protocol amendments/revisions and related documentation.
Other duties as assigned
Education Required - High school diploma or equivalent. Preferred degree: Bachelor's degree
Experience Required - Two years of related experience. With preferred degree, no experience required.
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