Clinical Research Coordinator II

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Full Time Professional LAKEWOOD RANCH, FL, US

9 days ago Requisition

We are looking for a dedicated Clinical Research Coordinator II with integrity and a passion for advancing medicine through research.

This position will work out of our Largo, FL location.

Job Summary: The Clinical Research Coordinator II’s primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study. Due to enhanced experience at FRI the Clinical Research Coordinator II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to community, sponsors, CRO’s and study participants and family members.

Our Culture:
Inspire hope. Build your legacy. Founded in 2011, Florida Digestive Health Specialists (FDHS) is the state's largest single-specialty, physician-owned gastroenterology practice. FDHS provides unparalleled, compassionate gastroenterology care. With a mission to provide the highest quality digestive health services while fostering advanced research to improve patient outcomes, FDHS offers comprehensive care across 30 locations in Florida. The team includes many “Top Doctors” recognized by Castle Connolly for their clinical excellence and dedication to the communities they serve.

This is a great organization to be a part of, so come join the team!

Duties include but are not limited to:

Study Preparation:

• Reviewandassessprotocol(including amendments) for clarity,logistical feasibility, subject safety, and inconsistencies, etc.
• Discussstudymedication,required procedures,eligibilitycriteriaandimpactonofficeflow with investigators and staff
• Assistwithplanningandcreationof appropriaterecruitmentmaterials
• Assistindevelopmentofrecruitmentplanandobtainlistingofpotentialcandidatesto contact from database
• Activelyworkwithrecruitmentteamincallingandrecruitingsubjectsforyourstudies and other site studies
• Participate in Investigator’smeetingand/orcoordinatepre-studysitevisitwithclinical staff and Sponsor/CRO representatives
• Create(orreviewsponsorprovided) protocolspecificsourcedocuments
• Determine facility,equipmentandoutsourcevendoravailability
• Ensureadequatesupplieshavearrivedonsiteforprotocolinitiation(labkits,study medication, specialized equipment, IVRS/EDC access and passwords)
• Ensureeducationofstaff and/orsub-investigators iscompletedforrequiredtasks

Study Management:

• Integratenewtrialloadwithexistingtrialloadandprioritizeactivitieswithregardto protocol timelines
• Maintain organized files forblanksourcedocuments,patientcharts,CRFs and supplies
• EDCentryofrequiredvisitswithin
  72hoursofvisitelementsbeingcompleted
• Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records
• Integratemonitoringvisitsandstudyteleconferencesintoexistingworkscheduletoallow for adequate preparation and time for interaction during these meetings
• Ensuretrialactivitiesarediscussedinadvancewithcoveringpersonnelincaseof vacation or sick leave
• MaintainadherencetoFDAregulationsandICHguidelinesinallaspectsofconducting clinical trials
• Communicatesponsorupdates,patientspecificconcerns/progress,unforeseen issues,and overall trial management with appropriate members of FRI team in an ongoing fashion
• Developandmaintain effectiverelationshipswithstudyparticipantsandFRIpersonnel
• Complete Endof Study Packets for Patient Liaisons
• Interactinapositive,professionalmannerwithpatients,sponsor representatives, offices/investigators, and FRI personnel
• Communicateclearlyverballyandinwriting
• Acceptaccountabilityforactionsandfunctionindependently
• Prescreenstudycandidatesbytelephoneandreviewexclusionaryconditionsor medications prior to scheduling screening appointment
• Contact scheduled Screening patients
  72hourspriorto
  
  Screeningappointmenttoverify pre-screened information has not changed
• Obtain informed consent per FRI SOP and document process. When revised ICF is receivedanddiscussedwithpatientsduringthetrialadequatedocumentationrequired
• Completevisitproceduresandensureproperspecimencollectionprocessingand shipment in accordance with protocol and lab manual
• Be prepared to complete basic clinical procedures,
  such as blood draws, vital signs, and ECGs
• Reviewlaboratoryresults,ECGs,andothertestresults(e.g.,biopsy results) for completeness and alert values, ensure investigator review in a timely fashion
• Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator.
  
  Ensure safety monitoringorsymptomatictreatmentisinitiatedasprescribedorasspecifiedinprotocol
• Schedule patients within visit windows (including any outside procedures-MRI, biopsy,…