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.Under the supervision of the Clinical Protocol Admin Mgr. assists the faculty investigator in the overall conduct of the clinical trials assigned maintaining adherence to the protocol, including but not limited to:·assistswithprotocolandconsentrevisionsasneeded,·assistswiththe IRB submissionprocessasneeded,·activelyparticipatesinprotocolmeetings,suchasinvestigatorandinitiationmeetings.·managesprotocolsatappropriateintervalsandparticipatesinmonitoringandaudit activities.·AppropriatelysubmitsinformationregardingadverseeventstotheIRB & sponsor EDCs·coordinates,evaluates,anddocumentspatientparticipationinclinicaltrials.Effectivelyfollowspatientsonprotocolbymaintainingknowledgeoftheiradverse eventsandresponsetotreatment.Appropriatelydocumentsfindingsinthemedicalrecordincollaborationwith physicians,mid-levelproviders,researchnurses,anddatamanagers.Contributes in the department of ID/IC/EH protocol review and submission process and attend protocols meetings.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. Designs and maintains research databases for the department and institutional databases for various research studies.Spends 50% or more time in direct patient contact.Obtains patient consenting for minimal risk studies. Follows-up protocol submission about research investigations, laboratory tests and responses. Assists the faculty investigator in data file preparation and attends data review meetings as required by the department. Prepares specific protocol reports and analysis and assist in continuing reviews and eSRC submissions. Participates and ensures prospective data collection is entered in a timely manner into the departmental database and/or study CRF/eCRF.Attends departmental meetings as required. Attends research team meetings.Dutiesmayalsoincludecollection andprocessingofspecimens.Coordinatestheacquisitionof researchbloodandothersamples. Manages,and orderstheconsumablelabsupplies necessarytomeetprotocolrequirementsforresearchspecimens. Other duties as required.