Clinical Research Coordinator II

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. Duties Study Preparation Reviewandassessprotocol(includingamendments)forclarity,logisticalfeasibility, subject safety, and inconsistencies, etc. Discussstudymedication,requiredprocedures,eligibilitycriteriaandimpactonoffice flow with investigators and staff Assistwithplanningandcreationof appropriaterecruitmentmaterials Assistindevelopmentofrecruitmentplanandobtainlistingofpotentialcandidatesto contact from database Activelyworkwithrecruitmentteamincallingandrecruitingsubjectsforyourstudies and other site studies ParticipateinInvestigator’smeetingand/orcoordinatepre-studysitevisitwithclinical staff and Sponsor/CRO representatives Create(orreviewsponsorprovided)protocolspecificsourcedocuments Determinefacility,equipmentandoutsourcevendoravailability Ensureadequatesupplieshavearrivedonsiteforprotocolinitiation(labkits,study medication, specialized equipment, IVRS/EDC access and passwords) Ensureeducationofstaff and/orsub-investigators iscompletedforrequiredtasks Study Management Integratenewtrialloadwithexistingtrialloadandprioritizeactivitieswithregardto protocol timelines Maintainorganized files forblanksourcedocuments,patientcharts,CRFs andsupplies EDCentryofrequiredvisitswithin72hoursofvisitelementsbeingcompleted 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,unforeseenissues,and overall trial management with appropriate members of FRI team in an ongoing fashion Developandmaintain effectiverelationshipswithstudyparticipantsandFRIpersonnel CompleteEndofStudyPacketsforPatientLiaisons Interactinapositive,professionalmannerwithpatients,sponsorrepresentatives, offices/investigators, and FRI personnel Communicateclearlyverballyandinwriting Acceptaccountabilityforactionsandfunctionindependently Patient Coordination Prescreenstudycandidatesbytelephoneandreviewexclusionaryconditionsor medications prior to scheduling screening appointment ContactscheduledScreeningpatients72hourspriortoScreeningappointmenttoverify 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.,biopsyresults)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, etc.),notifypersonnelasneededforprocedures,andintegratevisitswithexistingschedule to maximize efficient workflow and patient turnaround DispensestudymedicationperprotocolandorIVRSsystem.Educatepatientonproper administration and importance of compliance Monitorpatientprogressonstudymedication Documentation Recorddatalegibly,inrealtimeonsourcedocuments;noteadditionalinformationthat may assist with causality of adverse events, explain protocol deviations, or document patient progress.Correct errors per SOP Accurately record study medication inventory, medication, dispensation, and patient compliance.EnsureaccuratemaintenanceofdispensinglogsandIVRSconfirmations are conducted in a timely fashion Maintaincopiesofallprescriptionswrittenforstudyornon-studymedicationor procedures in patient chart AccuratelytranscribedatatoCRFs.Resolvedatamanagementqueriesandcorrectsource data as needed Recordprotocolexemptionsanddeviationsasappropriatewithsponsor - Complete Memo to File for patients’ charts and regulatory filing if necessary Ensureallsponsorcorrespondence(emails,telephoneconversations)areprintedand given to appropriate personnel for regulatory filing Maintaincopiesofpatient-specificcorrespondenceinsource charts Assistregulatorypersonnelwithcompletionofcontinuing/finalreviewreports Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all- inclusive. Knowledge, Skills, and Abilities Goodworkingknowledgeofmedical andresearchterminology Enhancedworkingknowledgeoffederalregulations,goodclinicalpractices (GCP) Abilitytomentorandguidelessexperienced CRCsas theydevelop andgain experience Abilitytocommunicateandworkeffectivelywithadiverseteamofprofessionals Excellentorganizational, prioritizationandleadershipskillsandcapabilities Strongcomputerskillswithdemonstratedabilitiesusingclinicaltrialsdatabase, electronic data capture, MS Word, and Excel Excellentinterpersonalskills,detailed-orientedandmeticulous Excellentprofessionalwritingandcommunicationskills Ability to work independently in a fast-paced environment with minimal supervision Experience Three years clinical research experience Three years Clinical Research Coordinator experience AminimumofoneyearasaFRIClinicalResearchCoordinatorIorcompletionofFRI CRC competency form License/Certification RNorLPNpreferred Research Professional Certificate- CCRC or exam eligibility preferred #J-18808-Ljbffr Florida Digestive Health Specialists