Work whereevery momentmattersEvery day more than 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 networkHartford Hospital is one of the largest and most respected teaching hospitals New England We are a Level Trauma Center that provides cuttingedge treatment to its patients This is made possible by being home to the largest robotic surgery center in the Northeast and the Center for Education Simulation and Innovation CESI one of the most advanced medical simulation training centers in the world When hospitals cannot provide the advanced care expertise and new treatment options their patients require they turn to usJob SummaryAs a specialized research professional the Clinical Research Associate CRA collaborates with the Principal Investigator PI in leading all activity associated with research study protocols This includes but is not limited to research conduct budget negotiation management initiating collaborations with other investigators and areas pertinent to the performance of the study monitoring research progress and making necessary changes towards process improvement leading efforts to initiate new studies attending IRB meetings to expedite the start up process The CRA supervises all study activity and may delegate responsibilities to Research Assistants andor Research Associates as appropriate In addition the CRA supervises HHC approved Research Volunteers While the Principal Investigator is primarily responsible for the overall design conduct and management of the clinical trial the CRA leads facilitates and coordinates all clinical trial activities playing a critical role in the supervision and conduct of the study By performing these duties the CRA works with the PI department sponsor IRB and institution to support and provide guidance on the administration of the compliance financial personnel and all aspects of the clinical studyJob ResponsibilitiesCompiles and extracts data by performing and reviewing patient information to ensure integrity of patient data for analysis and development of protocolsEnrolls patients in studies by screening for eligibility criteria consulting with physicians and obtaining patient informed consent to ensure patient safety preserved and regulatory standards are metInstructs hospital staff and physicians on current study by familiarizing them with protocol requirements to assure proper executionWorks effectively as a team member both within and across clinical settings to promote an integrated delivery of health care services through communication cooperation and collaborationTrain mentor and supervise lower level research staff students interns and volunteersAssign tasks to Clinical Research Assistants and Clinical Research Associates as appropriate in collaboration with the CRC managerSupport other staff in all aspects of study conduct including oversight associated with meeting the goals outlined in the protocol and clinical trial agreementMotivate others monitor study performance and lead study meetingsManage complex multisite interventional high risk drugdevice research protocolsPresents at conferences abstracts poster presentations and assists in preparation of manuscriptsMust have in depth knowledge of at least one clinical areaServe as CRC leader internalexternal advising other staff regarding complex protocols and projects in one or more clinical areaProvide a leadership role in developing implementing and evaluating the conduct of clinical researchTakes a lead role andor coordinates or presents at internal external clinical research education eventconferencesLead activities designed to improve organizational performance metricsReviews and develops a familiarity with the clinical trial agreement andor award terms and conditions Works with the PI to assure that the study is in compliance with all terms and conditions including but not limited to education IRB HRPP approval conflict of interest disclosure health and safety protections for participants and staff and any financial terms or conditionsCoordinates appropriate and timely payments to participants if applicable in accordance with policies and proceduresContributes directly regarding continued and yearly performance appraisal of Clinical Research Center team membersPromotes and monitors lower level personnel regarding the ethical conduct of research by assuring that good faith suspicions of misconduct in research as defined within Research Administrations Policy and other misconduct as described in HHC Code of Conduct are reported appropriatelyRegisters if required studies on ClinicalTrialsgov and maintains current and accurate informationCoordinates all aspects of study activity as required of a Clinical Research AssociateWork whereevery momentmattersEvery day more than 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 networkHartford Hospital is one of the largest and most respected teaching hospitals New England We are a Level Trauma Center that provides cuttingedge treatment to its patients This is made possible by being home to the largest robotic surgery center in the Northeast and the Center for Education Simulation and Innovation CESI one of the most advanced medical simulation training centers in the world When hospitals cannot provide the advanced care expertise and new treatment options their patients require they turn to usJob SummaryAs a specialized research professional the Clinical Research Associate CRA collaborates with the Principal Investigator PI in leading all activity associated with research study protocols This includes but is not limited to research conduct budget negotiation management initiating collaborations with other investigators and areas pertinent to the performance of the study monitoring research progress and making necessary changes towards process improvement leading efforts to initiate new studies attending IRB meetings to expedite the start up process The CRA supervises all study activity and may delegate responsibilities to Research Assistants andor Research Associates as appropriate In addition the CRA supervises HHC approved Research Volunteers While the Principal Investigator is primarily responsible for the overall design conduct and management of the clinical trial the CRA leads facilitates and coordinates all clinical trial activities playing a critical role in the supervision and conduct of the study By performing these duties the CRA works with the PI department sponsor IRB and institution to support and provide guidance on the administration of the compliance financial personnel and all aspects of the clinical studyJob ResponsibilitiesCompiles and extracts data by performing and reviewing patient information to ensure integrity of patient data for analysis and development of protocolsEnrolls patients in studies by screening for eligibility criteria consulting with physicians and obtaining patient informed consent to ensure patient safety preserved and regulatory standards are metInstructs hospital staff and physicians on current study by familiarizing them with protocol requirements to assure proper executionWorks effectively as a team member both within and across clinical settings to promote an integrated delivery of health care services through communication cooperation and collaborationTrain mentor and supervise lower level research staff students interns and volunteersAssign tasks to Clinical Research Assistants and Clinical Research Associates as appropriate in collaboration with the CRC managerSupport other staff in all aspects of study conduct including oversight associated with meeting the goals outlined in the protocol and clinical trial agreementMotivate others monitor study performance and lead study meetingsManage complex multisite interventional high risk drugdevice research protocolsPresents at conferences abstracts poster presentations and assists in preparation of manuscriptsMust have in depth knowledge of at least one clinical areaServe as CRC leader internalexternal advising other staff regarding complex protocols and projects in one or more clinical areaProvide a leadership role in developing implementing and evaluating the conduct of clinical researchTakes a lead role andor coordinates or presents at internal external clinical research education eventconferencesLead activities designed to improve organizational performance metricsReviews and develops a familiarity with the clinical trial agreement andor award terms and conditions Works with the PI to assure that the study is in compliance with all terms and conditions including but not limited to education IRB HRPP approval conflict of interest disclosure health and safety protections for participants and staff and any financial terms or conditionsCoordinates appropriate and timely payments to participants if applicable in accordance with policies and proceduresContributes directly regarding continued and yearly performance appraisal of Clinical Research Center team membersPromotes and monitors lower level personnel regarding the ethical conduct of research by assuring that good faith suspicions of misconduct in research as defined within Research Administrations Policy and other misconduct as described in HHC Code of Conduct are reported appropriatelyRegisters if required studies on ClinicalTrialsgov and maintains current and accurate informationCoordinates all aspects of study activity as required of a Clinical Research AssociateBachelors Degree Masters preferredAt least years of clinical trial management experienceExperience in all aspects of research recruitment of subjects IRB submission protocol set up etcRegistered Nurse in CT may be required for some projectsDemonstrated clinically competence with patient related measurements and high degree of accuracy with respect to documentation and data collectionDemonstrated initiative and excellent organizational skills in planning and executing study logisticsExperience in a clinical area eg Nursing Nuclear Medicine etcAbility to use time efficiently Outstanding interpersonal communications negotiation skills and enthusiasm Ability to work independently yet use good judgment in seeking advice when necessary Knowledge of research methodology data analysis statistical analysis and associated software is preferredWe 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 momentAs an Equal Opportunity EmployerAffirmative Action employer the organization will not discriminate in its employment practices due to an applicantrsquos race color religion sex sexual orientation gender identity national origin and veteran or disability statusBachelors Degree Masters preferredAt least years of clinical trial management experienceExperience in all aspects of research recruitment of subjects IRB submission protocol set up etcRegistered Nurse in CT may be required for some projectsDemonstrated clinically competence with patient related measurements and high degree of accuracy with respect to documentation and data collectionDemonstrated initiative and excellent organizational skills in planning and executing study logisticsExperience in a clinical area eg Nursing Nuclear Medicine etcAbility to use time efficiently Outstanding interpersonal communications negotiation skills and enthusiasm Ability to work independently yet use good judgment in seeking advice when necessary Knowledge of research methodology data analysis statistical analysis and associated software is preferredWe 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 momentAs an Equal Opportunity EmployerAffirmative Action employer the organization will not discriminate in its employment practices due to an applicantrsquos race color religion sex sexual orientation gender identity national origin and veteran or disability status