Job Title

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, 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. 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:Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staffAssist with planning and creation of appropriate recruitment materialsAssist in development of recruitment plan and obtain listing of potential candidates to contact from databaseActively work with recruitment team in calling and recruiting subjects for your studies and other site studiesParticipate in Investigator's meeting and /or coordinate pre-study site visit with clinical staff and Sponsor/CRO representativesCreate (or review sponsor provided) protocol specific source documentsDetermine facility, equipment and outsource vendor availabilityEnsure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)Ensure education of staff and/or sub-investigators is completed for required tasksStudy Management:Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelinesMaintain organized files for blank source documents, patient charts, CRFs and suppliesEDC entry of required visits within 72 hours of visit elements being completedInvestigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient recordsIntegrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetingsEnsure trial activities are discussed in advance with covering personnel in case of vacation or sick leaveMaintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trialsCommunicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of FRI team in an ongoing fashionDevelop and maintain effective relationships with study participants and FRI personnelComplete End of Study Packets for Patient LiaisonsInteract in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnelCommunicate clearly verbally and in writingAccept accountability for actions and function independentlyPatient Coordination:Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointmentContact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changedObtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation requiredComplete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manualBe prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGsReview laboratory results, ECGs, and other test results (e.g., biopsy results) for completeness and alert values, ensure investigator review in a timely fashionRecognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocolSchedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaroundDispense study medication per protocol and or IVRS system. Educate patient on proper administration and importance of complianceMonitor patient progress on study medication Documentation:Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOPAccurately record study medication inventory, medication, dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashionMaintain copies of all prescriptions written for study or non-study medication or procedures in patient chartAccurately transcribe data to CRFs. Resolve data management queries and correct source data as neededRecord protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients' charts and regulatory filing if necessaryEnsure all sponsor correspondence (emails, telephone conversations) are printed and given to appropriate personnel for regulatory filingMaintain copies of patient-specific correspondence in source chartsAssist regulatory personnel with completion of continuing/final review reportsPerform 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:Good working knowledge of medical and research terminologyEnhanced working knowledge of federal regulations, good clinical practices (GCP)Ability to mentor and guide less experienced CRCs as they develop and gain experienceAbility to communicate and work effectively with a diverse team of professionalsExcellent organizational, prioritization and leadership skills and capabilitiesStrong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and ExcelExcellent interpersonal skills, detailed-oriented and meticulousExcellent professional writing and communication skillsAbility to work independently in a fast-paced environment with minimal supervisionExperience:Two years clinical research experienceTwo years Clinical Research Coordinator experienceA minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency formLicense/Certification:RN or LPN preferredResearch Professional Certificate- CCRC or exam eligibility preferredWhen you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!