Clinical Trials Coordinator - Unlicensed

Stamford, CT, United States

Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed recordkeepingandregulatorycompliance,report writing,andcorrespondencewithinvestigators,sponsors/CROs,IRBs,andregulatoryauthorities.

Responsibleforthe new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance.

• Reviewinstitutionalreviewboardapprovedprotocolandprotocoldocumentspriortostudyactivationandpatient enrollment.
• Coordinate Studyfeasibilityandinitiation.
• Reviewpatientcharts,database records,andothersourcestoscreenandidentifypotentialsubjectsforinclusioninastudy.
• Attendsandparticipatesininvestigatormeetings,pre-study visits,andinitiationmeetingsorcoordinatormeetingsasappropriate.
• Communicatesstudyobjectivesandprocedurestoallrelevanthospitalunitsinvolvedwiththestudy,including the establishmentofgoodrapportwiththe
  
  Principal
  
  Investigatorandprovidinghim/herwiththerequiredassistance.
• Communicateswiththe Sponsororitsrepresentatives,schedulesandfacilitatesstudy
  
  Monitor visits,and facilitates communicationbetween
  
  Principal Investigator and Sponsoror Sponsor 'srepresentatives.
• Educate physicians,nurses,andancillarystaffregardinginvestigationalproduct,trial activities,and requirements.
• Meetwithpotentialsubjectsandtheirfamiliestoexplaintrialandtreatmentplan,andprovideemotionalandeducational support.
• Collectpertinentinformationanddatafromstudysubjectinterviews,charts,studyelectronicdevicesandothersources.
• Meetwithstudysponsorandregulatoryrepresentativestoreviewanddiscussconductofthetrial.
• Interactswithpatientsandfamiliestoensurecompliancewiththeprotocol.
• Obtainwritteninformedconsentforsubjecttoparticipateintrialpriortoperforminganystudy-related procedures.
• Coordinateresearchactivities,includingscheduleappointments,laboratory tests,radiologyandcardiologytesting.
• Assistswithmaintainingaccuraterecordsofthereceipt,inventory,anddispensationofstudydrugandmaterials.
• Assists the Director and Managerwithprotocolevaluationandfeasibility .
• 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.
• Utilizes Good Clinical Practicesintheconductofclinicaltrialsasperestablishedprotocol .Follows Stamford Hospital ’s Standard Operating Procedures ,AAHRPP,HIPPA,andFDAguidelinesforclinicalresearch,keepsupdatedwiththose procedures and/or guidelines, and complies with finance compliance policies and procedures.

• Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within
  18-24 months of hire date.
• Human Research Subject Protection and Good Clinical Practice Certification
• OSHAtrainingforhandlinghazardousbiologicandchemicalmaterials

• 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