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Coordinator, Clinical Studies - Lymphoma-Myeloma
Coordinator, Clinical Studies
MISSION 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, professionals, employees and the public.
SUMMARY
JOB SPECIFIC COMPETENCIES
Coordinates, evaluates and follows patient’s participation in clinical trials. Coordinates patient schedule to ensure protocol compliance.
Assist with submitting vial assignments as needed/requested.
EDUCATION
Ensures the conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations and institutional policies.
DATA COLLECTION/REPORTING
Assist in monitoring and evaluating patient response to the treatment protocol or research study by providing verbal and written or computerized reports. Assisting to gather the necessary data by talking with patients and/or reviewing patient’s medical records.
Report internal and external serious adverse events, if applicable, and follow up as needed. Grade toxicities and adverse reactions through personal interviews, by visually monitoring the medical record and/or by talking with the patient and/or family members and local physicians on the telephone. With the guidance of the PI and research nurse manager, reports treatment responses, toxicities and adverse treatment reactions to protocol/research sponsors and the Institutional Review Board (IRB) by providing regular written or computerized reports.
Checks the accuracy of protocol related data and provide protocol guidance to the Clinical Study and Research Data Coordinators.
SAMPLE MANAGEMENT
Coordinates the collection of patient samples for pharmacokinetic, pharmacodynamic, and other correlative laboratory studies. Coordinates for the collection of samples. Assist with ensuring research samples related to assigned protocols are being conducted in accordance with the protocol, troubleshooting as needed and developing processes to reduce the number of queries related to central laboratory samples.
ADMINISTRATIVE TASKS
Will assist in filing patient specific correspondences, protocol related forms within regulatory binder.
Will assist in maintaining redcap in conjunction with colleagues. Will file patient specific correspondences, protocol specific forms and any other items need to be housed in redcap to maintain protocol compliance. Assist with redacting patient documents to send with reports as needed. Assist with maintaining patient trackers or metrics as needed/request.
Other duties as assigned
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
