Stamford Health Medical Group
Clinical Trials Coordinator - Unlicensed
Stamford Health Medical Group, Stamford, Connecticut, United States, 06925
Clinical Trials Coordinator - Unlicensed
Stamford, CT, United States Job Description
Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct ofresearch trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed recordkeepingandregulatorycompliance,reportwriting,andcorrespondencewithinvestigators,sponsors/CROs,IRBs,andregulatoryauthorities.Responsibleforthe new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, andancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial andcontinuing education for Good Clinical Practice compliance. Responsibilities
Reviewinstitutionalreviewboardapprovedprotocolandprotocoldocumentspriortostudyactivationandpatient enrollment. CoordinateStudyfeasibilityandinitiation. Reviewpatientcharts,databaserecords,andothersourcestoscreenandidentifypotentialsubjectsforinclusioninastudy. Attendsandparticipatesininvestigatormeetings,pre-studyvisits,andinitiationmeetingsorcoordinatormeetingsasappropriate. Communicatesstudyobjectivesandprocedurestoallrelevanthospitalunitsinvolvedwiththestudy,includingthe establishmentofgoodrapportwiththePrincipalInvestigatorandprovidinghim/herwiththerequiredassistance. CommunicateswiththeSponsororitsrepresentatives,schedulesandfacilitatesstudyMonitorvisits,andfacilitates communicationbetweenPrincipalInvestigatorandSponsororSponsor'srepresentatives. Educatephysicians,nurses,andancillarystaffregardinginvestigationalproduct,trialactivities,andrequirements. Meetwithpotentialsubjectsandtheirfamiliestoexplaintrialandtreatmentplan,andprovideemotionalandeducational support. Collectpertinentinformationanddatafromstudysubjectinterviews,charts,studyelectronicdevicesandothersources. Meetwithstudysponsorandregulatoryrepresentativestoreviewanddiscussconductofthetrial. Interactswithpatientsandfamiliestoensurecompliancewiththeprotocol. Obtainwritteninformedconsentforsubjecttoparticipateintrialpriortoperforminganystudy-relatedprocedures. Coordinateresearchactivities,includingscheduleappointments,laboratorytests,radiologyandcardiologytesting. Assistswithmaintainingaccuraterecordsofthereceipt,inventory,anddispensationofstudydrugandmaterials. AssiststheDirectorandManagerwithprotocolevaluationandfeasibility. Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures. Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format. Prepareoroverseethepreparationofbiologicspecimensforshipmenttostudyreferencelaboratory. UtilizesGoodClinicalPracticesintheconductofclinicaltrialsasperestablishedprotocol.FollowsStamfordHospital’s StandardOperatingProcedures,AAHRPP,HIPPA,andFDAguidelinesforclinicalresearch,keepsupdatedwiththose procedures and/or guidelines, and complies with finance compliance policies and procedures. Qualifications
Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within18-24 months of hire date. HumanResearchSubjectProtectionandGoodClinicalPracticeCertification OSHAtrainingforhandlinghazardousbiologicandchemicalmaterials Job Info
Job Identification 4582 Job Category 300 - Professional Posting Date 08/27/2025, 07:33 PM Job Schedule Full time Job Shift Day Locations 1 Hospital Plaza, Stamford, CT, 06904, US
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Stamford, CT, United States Job Description
Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct ofresearch trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed recordkeepingandregulatorycompliance,reportwriting,andcorrespondencewithinvestigators,sponsors/CROs,IRBs,andregulatoryauthorities.Responsibleforthe new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, andancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial andcontinuing education for Good Clinical Practice compliance. Responsibilities
Reviewinstitutionalreviewboardapprovedprotocolandprotocoldocumentspriortostudyactivationandpatient enrollment. CoordinateStudyfeasibilityandinitiation. Reviewpatientcharts,databaserecords,andothersourcestoscreenandidentifypotentialsubjectsforinclusioninastudy. Attendsandparticipatesininvestigatormeetings,pre-studyvisits,andinitiationmeetingsorcoordinatormeetingsasappropriate. Communicatesstudyobjectivesandprocedurestoallrelevanthospitalunitsinvolvedwiththestudy,includingthe establishmentofgoodrapportwiththePrincipalInvestigatorandprovidinghim/herwiththerequiredassistance. CommunicateswiththeSponsororitsrepresentatives,schedulesandfacilitatesstudyMonitorvisits,andfacilitates communicationbetweenPrincipalInvestigatorandSponsororSponsor'srepresentatives. Educatephysicians,nurses,andancillarystaffregardinginvestigationalproduct,trialactivities,andrequirements. Meetwithpotentialsubjectsandtheirfamiliestoexplaintrialandtreatmentplan,andprovideemotionalandeducational support. Collectpertinentinformationanddatafromstudysubjectinterviews,charts,studyelectronicdevicesandothersources. Meetwithstudysponsorandregulatoryrepresentativestoreviewanddiscussconductofthetrial. Interactswithpatientsandfamiliestoensurecompliancewiththeprotocol. Obtainwritteninformedconsentforsubjecttoparticipateintrialpriortoperforminganystudy-relatedprocedures. Coordinateresearchactivities,includingscheduleappointments,laboratorytests,radiologyandcardiologytesting. Assistswithmaintainingaccuraterecordsofthereceipt,inventory,anddispensationofstudydrugandmaterials. AssiststheDirectorandManagerwithprotocolevaluationandfeasibility. Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures. Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format. Prepareoroverseethepreparationofbiologicspecimensforshipmenttostudyreferencelaboratory. UtilizesGoodClinicalPracticesintheconductofclinicaltrialsasperestablishedprotocol.FollowsStamfordHospital’s StandardOperatingProcedures,AAHRPP,HIPPA,andFDAguidelinesforclinicalresearch,keepsupdatedwiththose procedures and/or guidelines, and complies with finance compliance policies and procedures. Qualifications
Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within18-24 months of hire date. HumanResearchSubjectProtectionandGoodClinicalPracticeCertification OSHAtrainingforhandlinghazardousbiologicandchemicalmaterials Job Info
Job Identification 4582 Job Category 300 - Professional Posting Date 08/27/2025, 07:33 PM Job Schedule Full time Job Shift Day Locations 1 Hospital Plaza, Stamford, CT, 06904, US
#J-18808-Ljbffr