Clinical Research Coordinator II

Florida Digestive Health Specialists, LLP; Florida; On-site; USD 65,000 - 90,000; Full time

Job summary

Florida Research Institute, a division of Florida Digestive Health Specialists, LLP, is seeking a Clinical Research Coordinator II to screen, enroll, and follow study subjects while ensuring protocol and regulatory compliance. The role involves enhanced workload and stronger Sponsor/CRO interaction, reflecting increased experience at FRI.

We aim to convey a positive image of FRI to community members, sponsors, CROs and participants, while maintaining high standards of safety and data integrity

Qualifications

• RN or LPN preferred and licensed in good standing.
• Three years of Clinical Research Coordinator experience.
• Knowledge of Good Clinical Practice (GCP) and FDA regulations.

Responsibilities

• Screen, enroll and follow study subjects ensuring protocol compliance.
• Coordinate study preparation, materials and regulatory documentation.
• Communicate with sponsors, CROs and study staff to maintain study timelines.

Skills

GCP knowledge

MS Excel

Clinical trials

Mentoring CRCs

Education

RN or LPN preferred

CCRC/Research Certificate preferred

Tools

Electronic Data Capture (EDC)

MS Word

MS Excel

Job description

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 CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction,whileconveyingapositiveimageofFRItocommunity,sponsors,CRO’sandstudy participants and family members.

Our Culture: Inspire hope. Build your legacy.

Discover a rewarding, fulfilling, well-balanced career atFlorida Research Institute, a division of Florida Digestive Health Specialist, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.

Duties include but are not limited to:

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
• Interactinapositive,professionalmannerwithpatients,sponsorrepresentatives, offices/investigators, and FRI personnel
• Communicateclearlyverballyandinwriting
• Acceptaccountabilityforactionsandfunctionindependently
• 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

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
• 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
• Strongcomputerskillswithdemonstratedabilitiesusingclinicaltrialsdatabase, electronic data capture, MS Word, and Excel
• Excellentinterpersonalskills,detailed-orientedandmeticulous
• 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