Clinical Research Coordinator II - Lakewood Ranch

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Full Time Professional FLORIDA RESEARCH INSTITUTE, LAKEWOOD RANCH, FL, US

Salary Range: $61,000.00 To $68,000.00 Annually

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 at Florida 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(including amendments) for clarity,logistical feasibility, subject safety, and inconsistencies, etc.
• Discussstudymedication,required procedures,eligibilitycriteriaandimpactonoffice flow 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,patient charts,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…