MD Anderson Center
Coordinator, Clinical Studies (Protocol Manager Extender) - Leukemia
MD Anderson Center, Houston, Texas, United States, 77246
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 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
KEY FUNCTIONS
Protocol specific duties:
Under supervision of the protocol PI and the research nurse manager/supervisor research nurse staff assists the investigator and protocol managers by performing protocol-specific duties of the clinical trials including but not limited to assisting protocol serious adverse events (SAE) reporting, assisting in Quality Assurance (QA) procedure for reporting and monitoring Serious Adverse Events, tracking of protocol patients' outside reports laboratory results/ progress notes/ medical records administration in order to maintain protocol compliance, assisting protocol data queries, assisting in returned study medication accountability, actively participates in protocols meeting such as investigators and initiation meetings as required, performing a role of protocol manager liaison in the clinical trial.
Data participation:
Designs and maintains management reports on the databases for various research studies Provides guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards. Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
Assist the investigator in data file preparation and participates in data review meetings as required by the department. Enters data and maintains management reports on the databases for various research purposes. Prepares specific protocol reports to aid decisions regarding protocol summary and to assist in manuscript preparation and presentations.
Protocol monitoring:
Manages protocols at appropriate intervals and participates in monitoring and audit activities. Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Develops and maintains systems for the coding, editing, and computer entry of data for assigned research studies focusing on continuous patient follow-up.
EDUCATION
Required: Bachelor's degree.
EXPERIENCE
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required 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
KEY FUNCTIONS
Protocol specific duties:
Under supervision of the protocol PI and the research nurse manager/supervisor research nurse staff assists the investigator and protocol managers by performing protocol-specific duties of the clinical trials including but not limited to assisting protocol serious adverse events (SAE) reporting, assisting in Quality Assurance (QA) procedure for reporting and monitoring Serious Adverse Events, tracking of protocol patients' outside reports laboratory results/ progress notes/ medical records administration in order to maintain protocol compliance, assisting protocol data queries, assisting in returned study medication accountability, actively participates in protocols meeting such as investigators and initiation meetings as required, performing a role of protocol manager liaison in the clinical trial.
Data participation:
Designs and maintains management reports on the databases for various research studies Provides guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards. Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
Assist the investigator in data file preparation and participates in data review meetings as required by the department. Enters data and maintains management reports on the databases for various research purposes. Prepares specific protocol reports to aid decisions regarding protocol summary and to assist in manuscript preparation and presentations.
Protocol monitoring:
Manages protocols at appropriate intervals and participates in monitoring and audit activities. Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Develops and maintains systems for the coding, editing, and computer entry of data for assigned research studies focusing on continuous patient follow-up.
EDUCATION
Required: Bachelor's degree.
EXPERIENCE
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required 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