Address
Form of workMISSION STATEMENT
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, and professionals, employees, and the public.
SUMMARY
The primary purpose of the Coordinator, Clinical Studies is to provide day-to-day management, administrative oversight for clinical activities, and protocol compliance for the department of Pediatrics - Patient Care.
JOB-SPECIFIC COMPETENCIES
Coordination of Clinical Trials
Coordinate, evaluate, and follow patient progress while on studies maintaining knowledge of adverse events, protocol-related labs and research tests, and protocol responses.
Collaborate with the multidisciplinary team as necessary to achieve the objectives of the trial.
Collaborate with physicians, advanced practice providers, research nurses and, data managers to assure appropriate documentation of Patient Care and obtain the necessary information required by the protocol.
Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
Perform protocol-specific duties under the direct supervision of protocol PI, research nurses manager/supervisor as needed or appropriate.
Obtain informed consent for non-treatment studies and assist in obtaining informed consent for treatment studies by discussing the study requirements and answering any study-specific questions for the patient and family.
Screen study patients for and report adverse events as required per the trial sponsor.
Ensure that patients are scheduled for research-required tests and appointments by reviewing electronic health records and coordinating with schedules as needed.
Complete the clinical content template for new submission of protocols or protocol amendments that include changes to the treatment plan including required tests.
Creates and maintains delegation of authority log, as needed.
Creates and maintains study-specific training logs, as needed.
Ensures that data and regulatory documents are complete for audits and monitoring per standard operating procedures visits.
Prepare continuing reviews and annual reports.
Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
Data Coordination
Provides guidance and promotes protocol compliance in accordance with federal and institutional standards.
Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
Prepares data 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 and maintains records of source documents for data verification.
Clinical Trial Management
Collaborates with the research teams and study chair or protocol sponsor regarding protocol amendments, and withdrawals. Monitors revisions and amendments to protocols and revise collection sheets accordingly and timely.
Coordinate with the research teams and sponsors to ensure lab manuals and sample collection kits are developed correctly and are compliant with the amended protocol requirements.
Manages industry sponsor relations and acts as a liaison between sponsor representatives and the clinical team.
Participates in monitor visits. Performs QA audits to monitor compliance and accuracy of data.
Manages sponsor queries related to all aspects of research sample collection, processing, and shipment on study protocols, including accuracy of time points and quality of the final product.
Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction.
Responsible for kit management and inventory for all designated protocols.
Ensures stored research samples are properly obtained and managed per protocol.
Other duties as assigned
Requires flexibility in work schedule due to operational requirements. Attend meetings/work responsibilities outside of the set schedule.
REQUIREMENTS
Education: Bachelor's Degree in Health Sciences.
Preferred Education: Master's Level Degree
Certification: None
Preferred Certification: Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP)
Experience: Three years of experience in the area of research study or direct Patient Care obtained from nursing, data gathering, or other related experience. May substitute the required education degree with additional years of equivalent experience on a one-to-one basis. With the preferred degree, one year of experience is required.
Preferred Experience: Experience as a Sr. Research Data Coordinator.
Onsite Presence: Is 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
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, and professionals, employees, and the public.
SUMMARY
The primary purpose of the Coordinator, Clinical Studies is to provide day-to-day management, administrative oversight for clinical activities, and protocol compliance for the department of Pediatrics - Patient Care.
JOB-SPECIFIC COMPETENCIES
Coordination of Clinical Trials
Coordinate, evaluate, and follow patient progress while on studies maintaining knowledge of adverse events, protocol-related labs and research tests, and protocol responses.
Collaborate with the multidisciplinary team as necessary to achieve the objectives of the trial.
Collaborate with physicians, advanced practice providers, research nurses and, data managers to assure appropriate documentation of Patient Care and obtain the necessary information required by the protocol.
Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
Perform protocol-specific duties under the direct supervision of protocol PI, research nurses manager/supervisor as needed or appropriate.
Obtain informed consent for non-treatment studies and assist in obtaining informed consent for treatment studies by discussing the study requirements and answering any study-specific questions for the patient and family.
Screen study patients for and report adverse events as required per the trial sponsor.
Ensure that patients are scheduled for research-required tests and appointments by reviewing electronic health records and coordinating with schedules as needed.
Complete the clinical content template for new submission of protocols or protocol amendments that include changes to the treatment plan including required tests.
Creates and maintains delegation of authority log, as needed.
Creates and maintains study-specific training logs, as needed.
Ensures that data and regulatory documents are complete for audits and monitoring per standard operating procedures visits.
Prepare continuing reviews and annual reports.
Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
Data Coordination
Provides guidance and promotes protocol compliance in accordance with federal and institutional standards.
Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
Prepares data 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 and maintains records of source documents for data verification.
Clinical Trial Management
Collaborates with the research teams and study chair or protocol sponsor regarding protocol amendments, and withdrawals. Monitors revisions and amendments to protocols and revise collection sheets accordingly and timely.
Coordinate with the research teams and sponsors to ensure lab manuals and sample collection kits are developed correctly and are compliant with the amended protocol requirements.
Manages industry sponsor relations and acts as a liaison between sponsor representatives and the clinical team.
Participates in monitor visits. Performs QA audits to monitor compliance and accuracy of data.
Manages sponsor queries related to all aspects of research sample collection, processing, and shipment on study protocols, including accuracy of time points and quality of the final product.
Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction.
Responsible for kit management and inventory for all designated protocols.
Ensures stored research samples are properly obtained and managed per protocol.
Other duties as assigned
Requires flexibility in work schedule due to operational requirements. Attend meetings/work responsibilities outside of the set schedule.
REQUIREMENTS
Education: Bachelor's Degree in Health Sciences.
Preferred Education: Master's Level Degree
Certification: None
Preferred Certification: Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP)
Experience: Three years of experience in the area of research study or direct Patient Care obtained from nursing, data gathering, or other related experience. May substitute the required education degree with additional years of equivalent experience on a one-to-one basis. With the preferred degree, one year of experience is required.
Preferred Experience: Experience as a Sr. Research Data Coordinator.
Onsite Presence: Is 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
