Bridgeport, Connecticut, USA
11 days ago
Clinical Research Coordinator ll
Work where everymomentmattersEvery day over Hartford HealthCare colleagues come to work with one thing in common Pride in what we do knowing every moment matters here We invite you to become part of Connecticutrsquos most comprehensive healthcare networkThe Hartford HealthCare Cancer Institute focuses on offering our cancer patients an unparalleled network of coordinated servicesndash all under one roof Our system of care includes a truly integrated team with the most talented experienced and compassionate caregivers and physicians backed by the latest cutting edge technology This includes our new MSK Care Partners program that furthers the Cancer Institutersquos focus to provide the newest and most effective approaches to cancer care within the community based on scientific evidence The Clinical Research Coordinator ll of Cancer Clinical Research Office CCRO is an integral member of the research team This position is based in our Fairfield Region St Vincentrsquos Medical Center and will support a portfolio of cancer research studies In compliance with all regulatory institutional and departmental requirements performs patient screening data collection and data entry for research protocols databases and projects within Hartford Healthcare Cancer Institute and ensures the data quality and integrity for each clinical trialResponsibilitiesbull Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI industry cooperative groups or HHC system alliancesbull Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment informed consent continuous monitoring of protocol for compliance and patient safety source document review data entry sponsor monitoringbull Interactcollaborate with all physicians other members of the health care team and participantsfamilies across the system in a manner that supports the conduct of clinical trialsbull Required to attend the respective system wide Disease Management Team meetings and present the clinical trials to potential investigatorsbull Collaborate with and support other clinical trial staff across the system to ensure highest quality clinical research activitiesbull Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelinesbull Prepare study calendars and materials maintain participant tracking logs and screeningenrollment logsbull Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations safety reporting and continuing reviewsbull Assist research account specialist of CCRO with clinical trial billing in the resolution of related queriesbull Assistcoordinate preparation for internal and external auditsWork where everymomentmattersEvery day over Hartford HealthCare colleagues come to work with one thing in common Pride in what we do knowing every moment matters here We invite you to become part of Connecticutrsquos most comprehensive healthcare networkThe Hartford HealthCare Cancer Institute focuses on offering our cancer patients an unparalleled network of coordinated servicesndash all under one roof Our system of care includes a truly integrated team with the most talented experienced and compassionate caregivers and physicians backed by the latest cutting edge technology This includes our new MSK Care Partners program that furthers the Cancer Institutersquos focus to provide the newest and most effective approaches to cancer care within the community based on scientific evidence The Clinical Research Coordinator ll of Cancer Clinical Research Office CCRO is an integral member of the research team This position is based in our Fairfield Region St Vincentrsquos Medical Center and will support a portfolio of cancer research studies In compliance with all regulatory institutional and departmental requirements performs patient screening data collection and data entry for research protocols databases and projects within Hartford Healthcare Cancer Institute and ensures the data quality and integrity for each clinical trialResponsibilitiesbull Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI industry cooperative groups or HHC system alliancesbull Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment informed consent continuous monitoring of protocol for compliance and patient safety source document review data entry sponsor monitoringbull Interactcollaborate with all physicians other members of the health care team and participantsfamilies across the system in a manner that supports the conduct of clinical trialsbull Required to attend the respective system wide Disease Management Team meetings and present the clinical trials to potential investigatorsbull Collaborate with and support other clinical trial staff across the system to ensure highest quality clinical research activitiesbull Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelinesbull Prepare study calendars and materials maintain participant tracking logs and screeningenrollment logsbull Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations safety reporting and continuing reviewsbull Assist research account specialist of CCRO with clinical trial billing in the resolution of related queriesbull Assistcoordinate preparation for internal and external auditsEducationBachelorrsquos degree in Nursing Pharmacy or Healthcare relatedQualificationsbull Minimum of years of relevant clinical research experiencebull Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collectionbull Ability to work with spreadsheets such as Excel familiarity with databases ex Medidata RAVE IRIS NSABP GOG RTOG etc and queryingbull Experience with Microsoft Access Excel and electronic data capture systemsbull Experience in preparing and completing Case Report Forms CRFrsquos eligibility checklist and other relevant documentation protocolsbull Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated teambull Ability to travel between clinical sites whenever required This includes travel to Hartford for required training and on boardingWe take great care of careersWith locations around the state Hartford HealthCare offers exciting opportunities for career development and growth Here you are part of an organization on the cutting edge ndash helping to bring new technologies breakthrough treatments and community education to countless men women and children We know that a thriving organization starts with thriving employees we provide a competitive benefits program designed to ensure worklife balance Every moment matters And this isyour momentEducationBachelorrsquos degree in Nursing Pharmacy or Healthcare relatedQualificationsbull Minimum of years of relevant clinical research experiencebull Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collectionbull Ability to work with spreadsheets such as Excel familiarity with databases ex Medidata RAVE IRIS NSABP GOG RTOG etc and queryingbull Experience with Microsoft Access Excel and electronic data capture systemsbull Experience in preparing and completing Case Report Forms CRFrsquos eligibility checklist and other relevant documentation protocolsbull Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated teambull Ability to travel between clinical sites whenever required This includes travel to Hartford for required training and on boardingWe take great care of careersWith locations around the state Hartford HealthCare offers exciting opportunities for career development and growth Here you are part of an organization on the cutting edge ndash helping to bring new technologies breakthrough treatments and community education to countless men women and children We know that a thriving organization starts with thriving employees we provide a competitive benefits program designed to ensure worklife balance Every moment matters And this isyour moment
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