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Clinical Research Coordinator (Retina & AI-O | Clinical Coordinator, Clinical Research Coordin1

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Clinical Research Coordinator (Retina & AI-O

Location:
Chicago, IL
Description:

Job Summary: This position manages and coordinates the timely handling of all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting for the Retina Davison and Artificial Intelligence in Ophthalmology (AI-O) center within the Department of Ophthalmology & Visual Sciences. Responsible for the implementation and conducting of multiple research projects. Coordinates comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements. Develops and implements effective patient recruitment strategies. Oversees and participates in subject recruitment, screening, scheduling, testing, and data management for a multi-faceted investigation. Essential Duties Assist in establishing and coordinating the implementation of clinical research protocol priorities and organization structure.Notify and inform physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program.Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), the UIC Institutional Biosafety Committee (IBC), the UIC Research Finance Office (CRFO), the UIC Office of Sponsored Programs (OSP), other regulatory agencies and grant sponsors.Compose and revise study protocols, informed consents and patient recruitment materials when needed.Work closely with Pre Award, Post Award, Department Accounting and Sponsor regarding patient billing.Communicate with UIC Compliance regarding hospital pricing. Create itemized study budget, make timely coverage analysis review request to CRFO, negotiate study budget with grant sponsorsAssist Post Award with clinical trial close out. Reconcile internal bills, close human subjects program advances, etc.Act as liaison between physicians, clinical staff and the UIC offices, CROs, grant sponsors and regulatory agencies to ensure priorities are clearly communicated, timelines are caught and resources are allocated appropriately across multiple ongoing projects.Communicate clinical information and work with stakeholders to create best practice tools.Assist in study eye exams and study treatment; participate in research activities involving ophthalmic imaging and ultrasonography; check vital signs, collect, process or ship samples including surgical specimens.Assist study photographers in study imaging uploading to reading centers, data repositories, and databases.Conduct monitoring phone calls and on-site visits with CROs and sponsors.Enter study data to EDC and solve queries within required timelines of grant sponsors.Store, monitor and dispense study medications, monitor and record storage temperatures on daily basis.Store, organize and monitor inventory of study device and supplies, order when inventory is low, and return to sponsors when required at the end of clinical trials.Create study source documents and data collection forms per study requirements.Collect study team members' signatures on study documents (if wet ink, from eye clinic and offices) in a timely manner.Assist physicians and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.Analyze retention rates and formulates plans to retain participants. Coordinate outreach to and liaison with staff at schools, community clinics, science fairs, etc. to make research presentations and recruit new participants for various research projects by reviewing clinical schedules, identifying patients, and order entry.Execute informed consent process and monitors patient status; Enroll participants into programs, explaining the research protocols to the clients and supporting family/friends, and obtain appropriate consent forms.Ensure that participant enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.Participate in conducting surveys of participants and supporting family/friends.Collect and review client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors. Evaluate data to determine project effectivenessAssist investigators in preparing study data, literature reviews, analysis for meeting presentations and publications.Work with study team and clinic managers to ensure and assist completion of timely training and study certifications for study team members and study device.Train and continue to organize and work with junior coordinators, undergraduate students, medical students, residents, fellows on new and ongoing research projects. Maintain submissions required by regulatory agencies and perform as a resource for study team on study-related issues.Participate in continuing education and training.Attend investigator and coordinator meetings domestically.Maintain, arrange, and coordinate existing and new entries for clinical research databases including ophthalmic imaging databases and collaborations within and outside of UIC including Microsoft Excel, REDCap, Box folders, and backup physical hard drives while ensuring strict IRB, health data regulation, and HIPAA compliance.Liaison with the UIHealth biorepository, IRB, and outside centers for requests including frozen tissue specimens, tissue blocks, and imaging requests.Communicate and liaison with the researchers, collaborators, UIC core resources and the cancer center for data requests and research collaborations including lab meetings for new and existing project updates and think tanks.Monitor, organize, and coordinate existing and new specimen contributions to the ophthalmic biorepository from clinic and surgery including patients with ocular tumors.Maintain the Cless Ophthalmic Surgical Training and Simulation Center for surgical researchData collection, organization, maintenance, and transfer for research projects and collaborations including those within the Ai-O CenterAssist principal investigator in grant and manuscript submission.Performs other duties and special projects as assigned. Minimum Qualifications Bachelor degree in nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field required. At least one year experience in a research discipline required. Experience in a clinical research setting, experience working with Federal Regulations and IRB's required. Prior experience with medical terminology and procedures including electronic medical records and billing preferred. Ability to manage multiple tasks. Strong interpersonal and customer service skills. Requires excellent communication, organization, presentation and computer/pc skills. Proficiency in Microsoft Office and other related software. Knowledge of research protocols, principles and procedures; knowledge of aspects of clinical trials such as screening, interviewing, case reports forms; knowledge of experimental design, mathematics, statistics, computer applications and computer data management; oral and written communication skills; knowledge of a science such as biology or psychology; ability to identify, produce, organize, evaluate and interpret data; knowledge of ethics and regulatory procedures (i.e. informed consent, IRB applications, data safety and monitoring plans) involved with clinical trials and other clinical research; ability to work as a member of a project team; knowledge of clinical tasks required for research (e.g. phlebotomy, centrifugation, interviewing). Preferred Qualifications Certified Clinical Research Coordinator (CCRC) preferred. To apply, please visit: https://uic.csod.com/ux/ats/careersite/1/home/requisition/8378?c=uic and upload: Resume Names and contact information for 3 references For fullest consideration, please submit an application by March 1, 2024 https://uic.csod.com/ux/ats/careersite/1/home/requisition/7945?c=uic The University of Illinois conducts background checks on all job candidates upon acceptance of contingent offer employments. Background checks will be performed in compliance with the Fair Credit Report Act.The University of Illinois at Chicago is an affirmative action, equal opportunity employer that has a strong institutional commitment to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. We are committed to equal employment opportunities regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.The University of Illinois System requires candidates selected for hire to disclose any documented finding of sexual misconduct or sexual harassment and to authorize inquiries to current and former employers regarding findings of sexual misconduct or sexual harassment. For more information, visit https://www.hr.uillinois.edu/cms/One.aspx?portalId=4292&pageId=1411899 PDN-9b726277-d8d7-432b-b528-cd24f939d79b
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