MD Anderson Cancer Center Quality Assurance Specialist - Protocol Research 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.
Provide quality assurance support for the Office of Protocol Research.
Serve as an expert source of knowledge human subjects protection issues.
Supports faculty and research teams by responding to compliance concerns. Supports internal and external auditors by coordinating information requests. Provides human protection training courses as needed. Writes articles for the Human Subject Research Bulletin. Generates correspondence to the institution on compliance initiatives.
Conducts regulatory audits of OPR processes and procedures as required.
Conducts reviews and audits of human subject regulatory processes or compliance issues. Communicates progress and findings by preparing reports and providing information in meetings. Initiates follow-up for compliance issues, as needed. Participates in ad hoc meetings.
Oversees the timelines in place for the review and processing of protocol amendments.
Provides a vital resource by supporting the Institutional Review Board by providing ongoing regulatory monitoring and quality assurance checks for the IRB processes related to the review of protocol amendments. Will also ensure correspondence submitted to the IRB is appropriately triaged and that the needed guidance requested by the research teams is obtained. This would also include requests for the status of submitted protocol amendments. Responsible for the following:
• Review of protocol amendments submitted for compilation of daily protocol list for distribution to CR-Ops, CRF, Investigational Pharmacy
• Tracking of protocol amendments as they enter the amendment IRB review and process workflow based on established deadlines
• Notifications to IRB reviewers and IRB staff regarding approaching amendment review deadlines
• Quality Assurance checks of the IRB amendment review process
• Provide report to IRB Manager of status of pending amendments
• Review of metrics reports for amendment and discussion with IRB Manager
Maintains departmental standard operating procedures for the Quality Assurance process and assists in the development of policies as needed.
Maintains operating procedures for individual process. Conducts self-audit of process and reports findings to leadership as needed. Develops compliance policies for other areas as needed. Assure appropriate documentation is maintained as mandated by the federal regulatory requirements.
Required: Bachelor's degree in Healthcare, Nursing or a related healthcare field.
Preferred: Master's degree.
Required: Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on a one to one basis.
Preferred: Five years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable.
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