Clinical Research Coordinator II

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    "requisitionDescription": "<div><div><div><div><div><div><div><div><div><div><p data-pasted=\"true\"><strong>Job Summary:&nbsp;</strong>The Clinical Research Coordinator II&rsquo;s primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study.&nbsp;Due to enhanced experience at FRI the CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction,&nbsp;while&nbsp;conveying&nbsp;a&nbsp;positive&nbsp;image&nbsp;of&nbsp;FRI&nbsp;to&nbsp;community,&nbsp;sponsors,&nbsp;CRO&rsquo;s&nbsp;and&nbsp;study participants and family members.</p><p><strong data-pasted=\"true\">Our Culture: Inspire hope. Build your legacy.&nbsp;</strong>Discover a rewarding, fulfilling, well-balanced career at&nbsp;<a href=\"https://www.floridaresearchinst.com/\" target=\"_blank\" rel=\"noopener noreferrer\">Florida Research Institute</a>, 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.&nbsp;</p><p><strong>Duties include but are not limited to:</strong></p><p><strong>Study Preparation:</strong></p><ul type=\"disc\"><li>Review&nbsp;and&nbsp;assess&nbsp;protocol&nbsp;(including&nbsp;amendments)&nbsp;for&nbsp;clarity,&nbsp;logistical&nbsp;feasibility, subject safety, and inconsistencies, etc.</li><li>Discuss&nbsp;study&nbsp;medication,&nbsp;required&nbsp;procedures,&nbsp;eligibility&nbsp;criteria&nbsp;and&nbsp;impact&nbsp;on&nbsp;office flow with investigators and staff</li><li>Assist&nbsp;with&nbsp;planning&nbsp;and&nbsp;creation&nbsp;of appropriate&nbsp;recruitment&nbsp;materials</li><li>Assist&nbsp;in&nbsp;development&nbsp;of&nbsp;recruitment&nbsp;plan&nbsp;and&nbsp;obtain&nbsp;listing&nbsp;of&nbsp;potential&nbsp;candidates&nbsp;to contact from database</li><li>Actively&nbsp;work&nbsp;with&nbsp;recruitment&nbsp;team&nbsp;in&nbsp;calling&nbsp;and&nbsp;recruiting&nbsp;subjects&nbsp;for&nbsp;your&nbsp;studies and other site studies</li><li>Participate&nbsp;in&nbsp;Investigator&rsquo;s&nbsp;meeting&nbsp;and&nbsp;/or&nbsp;coordinate&nbsp;pre-study&nbsp;site&nbsp;visit&nbsp;with&nbsp;clinical staff and Sponsor/CRO representatives</li><li>Create&nbsp;(or&nbsp;review&nbsp;sponsor&nbsp;provided)&nbsp;protocol&nbsp;specific&nbsp;source&nbsp;documents</li><li>Determine&nbsp;facility,&nbsp;equipment&nbsp;and&nbsp;outsource&nbsp;vendor&nbsp;availability</li><li>Ensure&nbsp;adequate&nbsp;supplies&nbsp;have&nbsp;arrived&nbsp;on&nbsp;site&nbsp;for&nbsp;protocol&nbsp;initiation&nbsp;(lab&nbsp;kits,&nbsp;study medication, specialized equipment, IVRS/EDC access and passwords)</li><li>Ensure&nbsp;education&nbsp;of&nbsp;staff and/or&nbsp;sub-investigators is&nbsp;completed&nbsp;for&nbsp;required&nbsp;tasks</li></ul><p><strong>Study Management:</strong></p><ul type=\"disc\"><li>Integrate&nbsp;new&nbsp;trial&nbsp;load&nbsp;with&nbsp;existing&nbsp;trial&nbsp;load&nbsp;and&nbsp;prioritize&nbsp;activities&nbsp;with&nbsp;regard&nbsp;to protocol timelines</li><li>Maintain&nbsp;organized files for&nbsp;blank&nbsp;source&nbsp;documents,&nbsp;patient&nbsp;charts,&nbsp;CRFs and&nbsp;supplies</li><li>EDC&nbsp;entry&nbsp;of&nbsp;required&nbsp;visits&nbsp;within&nbsp;72&nbsp;hours&nbsp;of&nbsp;visit&nbsp;elements&nbsp;being&nbsp;completed</li><li>Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records</li><li>Integrate&nbsp;monitoring&nbsp;visits&nbsp;and&nbsp;study&nbsp;teleconferences&nbsp;into&nbsp;existing&nbsp;work&nbsp;schedule&nbsp;to&nbsp;allow for adequate preparation and time for interaction during these meetings</li><li>Ensure&nbsp;trial&nbsp;activities&nbsp;are&nbsp;discussed&nbsp;in&nbsp;advance&nbsp;with&nbsp;covering&nbsp;personnel&nbsp;in&nbsp;case&nbsp;of vacation or sick leave</li><li>Maintain&nbsp;adherence&nbsp;to&nbsp;FDA&nbsp;regulations&nbsp;and&nbsp;ICH&nbsp;guidelines&nbsp;in&nbsp;all&nbsp;aspects&nbsp;of&nbsp;conducting clinical trials</li><li>Communicate&nbsp;sponsor&nbsp;updates,&nbsp;patient&nbsp;specific&nbsp;concerns/progress,&nbsp;unforeseen&nbsp;issues,&nbsp;and overall trial management with appropriate members of FRI team in an ongoing fashion</li><li>Develop&nbsp;and&nbsp;maintain effective&nbsp;relationships&nbsp;with&nbsp;study&nbsp;participants&nbsp;and&nbsp;FRI&nbsp;personnel</li><li>Complete&nbsp;End&nbsp;of&nbsp;Study&nbsp;Packets&nbsp;for&nbsp;Patient&nbsp;Liaisons</li><li>Interact&nbsp;in&nbsp;a&nbsp;positive,&nbsp;professional&nbsp;manner&nbsp;with&nbsp;patients,&nbsp;sponsor&nbsp;representatives, offices/investigators, and FRI personnel</li><li>Communicate&nbsp;clearly&nbsp;verbally&nbsp;and&nbsp;in&nbsp;writing</li><li>Accept&nbsp;accountability&nbsp;for&nbsp;actions&nbsp;and&nbsp;function&nbsp;independently</li></ul><p><strong>Patient Coordination:</strong></p><ul type=\"disc\"><li>Prescreen&nbsp;study&nbsp;candidates&nbsp;by&nbsp;telephone&nbsp;and&nbsp;review&nbsp;exclusionary&nbsp;conditions&nbsp;or medications prior to scheduling screening appointment</li><li>Contact&nbsp;scheduled&nbsp;Screening&nbsp;patients&nbsp;72&nbsp;hours&nbsp;prior&nbsp;to&nbsp;Screening&nbsp;appointment&nbsp;to&nbsp;verify pre-screened information has not changed</li><li>Obtain informed consent per FRI SOP and document process. When revised ICF is received&nbsp;and&nbsp;discussed&nbsp;with&nbsp;patients&nbsp;during&nbsp;the&nbsp;trial&nbsp;adequate&nbsp;documentation&nbsp;required</li><li>Complete&nbsp;visit&nbsp;procedures&nbsp;and&nbsp;ensure&nbsp;proper&nbsp;specimen&nbsp;collection&nbsp;processing&nbsp;and shipment in accordance with protocol and lab manual</li><li>Be prepared to complete basic clinical procedures, <strong>such as blood draws, vital signs, and ECGs</strong></li><li>Review&nbsp;laboratory&nbsp;results,&nbsp;ECGs,&nbsp;and&nbsp;other&nbsp;test&nbsp;results&nbsp;(e.g.,&nbsp;biopsy&nbsp;results)&nbsp;for completeness and alert values, ensure investigator review in a timely fashion</li><li>Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator.&nbsp;Ensure safety monitoring&nbsp;or&nbsp;symptomatic&nbsp;treatment&nbsp;is&nbsp;initiated&nbsp;as&nbsp;prescribed&nbsp;or&nbsp;as&nbsp;specified&nbsp;in&nbsp;protocol</li><li>Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.),&nbsp;notify&nbsp;personnel&nbsp;as&nbsp;needed&nbsp;for&nbsp;procedures,&nbsp;and&nbsp;integrate&nbsp;visits&nbsp;with&nbsp;existing&nbsp;schedule to maximize efficient workflow and patient turnaround</li><li>Dispense&nbsp;study&nbsp;medication&nbsp;per&nbsp;protocol&nbsp;and&nbsp;or&nbsp;IVRS&nbsp;system.&nbsp;Educate&nbsp;patient&nbsp;on&nbsp;proper administration and importance of compliance</li><li>Monitor&nbsp;patient&nbsp;progress&nbsp;on&nbsp;study&nbsp;medication</li></ul><p><strong>&nbsp;Documentation:</strong></p><ul type=\"disc\"><li>Record&nbsp;data&nbsp;legibly,&nbsp;in&nbsp;real&nbsp;time&nbsp;on&nbsp;source&nbsp;documents;&nbsp;note&nbsp;additional&nbsp;information&nbsp;that may assist with causality of adverse events, explain protocol deviations, or document patient progress.&nbsp;Correct errors per SOP</li><li>Accurately record study medication inventory, medication, dispensation, and patient compliance.&nbsp;Ensure&nbsp;accurate&nbsp;maintenance&nbsp;of&nbsp;dispensing&nbsp;logs&nbsp;and&nbsp;IVRS&nbsp;confirmations are conducted in a timely fashion</li><li>Maintain&nbsp;copies&nbsp;of&nbsp;all&nbsp;prescriptions&nbsp;written&nbsp;for&nbsp;study&nbsp;or&nbsp;non-study&nbsp;medication&nbsp;or procedures in patient chart</li><li>Accurately&nbsp;transcribe&nbsp;data&nbsp;to&nbsp;CRFs.&nbsp;Resolve&nbsp;data&nbsp;management&nbsp;queries&nbsp;and&nbsp;correct&nbsp;source data as needed</li><li>Record&nbsp;protocol&nbsp;exemptions&nbsp;and&nbsp;deviations&nbsp;as&nbsp;appropriate&nbsp;with&nbsp;sponsor - Complete Memo to File for patients&rsquo; charts and regulatory filing if necessary</li><li>Ensure&nbsp;all&nbsp;sponsor&nbsp;correspondence&nbsp;(emails,&nbsp;telephone&nbsp;conversations)&nbsp;are&nbsp;printed&nbsp;and given to appropriate personnel for regulatory filing</li><li>Maintain&nbsp;copies&nbsp;of&nbsp;patient-specific&nbsp;correspondence&nbsp;in&nbsp;source charts</li><li>Assist&nbsp;regulatory&nbsp;personnel&nbsp;with&nbsp;completion&nbsp;of&nbsp;continuing/final&nbsp;review&nbsp;reports</li><li>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.</li></ul><p><strong>Knowledge, Skills, and Abilities:</strong></p><ul type=\"disc\"><li>Good&nbsp;working&nbsp;knowledge&nbsp;of&nbsp;medical and&nbsp;research&nbsp;terminology</li><li>Enhanced&nbsp;working&nbsp;knowledge&nbsp;of&nbsp;federal&nbsp;regulations,&nbsp;good&nbsp;clinical&nbsp;practices (GCP)</li><li>Ability&nbsp;to&nbsp;mentor&nbsp;and&nbsp;guide&nbsp;less&nbsp;experienced CRCs&nbsp;as they&nbsp;develop and&nbsp;gain experience</li><li>Ability&nbsp;to&nbsp;communicate&nbsp;and&nbsp;work&nbsp;effectively&nbsp;with&nbsp;a&nbsp;diverse&nbsp;team&nbsp;of&nbsp;professionals</li><li>Excellent&nbsp;organizational, prioritization&nbsp;and&nbsp;leadership&nbsp;skills&nbsp;and&nbsp;capabilities</li><li>Strong&nbsp;computer&nbsp;skills&nbsp;with&nbsp;demonstrated&nbsp;abilities&nbsp;using&nbsp;clinical&nbsp;trials&nbsp;database, electronic data capture, MS Word, and Excel</li><li>Excellent&nbsp;interpersonal&nbsp;skills,&nbsp;detailed-oriented&nbsp;and&nbsp;meticulous</li><li>Excellent&nbsp;professional&nbsp;writing&nbsp;and&nbsp;communication&nbsp;skills</li><li>Ability to work independently in a fast-paced environment with minimal supervision</li></ul><p><strong>Experience:</strong></p><ul type=\"disc\"><li>Three years clinical research experience</li><li>Three years Clinical Research Coordinator experience</li><li>A&nbsp;minimum&nbsp;of&nbsp;one&nbsp;year&nbsp;as&nbsp;a&nbsp;FRI&nbsp;Clinical&nbsp;Research&nbsp;Coordinator&nbsp;I&nbsp;or&nbsp;completion&nbsp;of&nbsp;FRI CRC competency form</li></ul><p><strong>License/Certification:</strong></p><ul type=\"disc\"><li>RN&nbsp;or&nbsp;LPN&nbsp;preferred</li><li>Research Professional Certificate- CCRC or exam eligibility preferred</li></ul><p><strong data-pasted=\"true\">&shy;</strong>When 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!</p></div></div></div></div></div></div></div></div></div></div>\n",
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