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Title Clinical Research Coordinator
Target Location US-SC-Columbia
Email Available with paid plan
Phone Available with paid plan
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CourtneySeasePHONE NUMBER AVAILABLEEMAIL AVAILABLESUMMARYA quality driven Clinical Research Coordinator, with 11 years of research experience seeking a stable, challenging position that will enable me to use my proficient skills in coordinating multiple clinical trials. I offer familiarity with study protocols, standard operating procedures, and good clinical practices which makes me an ideal candidate for a team-based environment.SKILLSLexington, SC 29073  IRB Microsoft Office Communication Skills Compliance Clinical Research Detailed OrientedEXPERIENCE Data analysis Good Clinical Practice Scheduling Proficiency Phlebotomy Specimen Handling Research ExperienceClinical Research CoordinatorOrangeburg, SCSC Clinical Research, LLC/ Dec 2023 to present Independently and strategically recruit patients to be in research trials, as appropriate and develop and maintain source documents for upcoming studies Obtain informed consents, all needed demographics, medical history, and concomitant medications from subjects who meet protocol criteria. Collect study related clinical assessments: vital signs, blood samples, and electrocardiograms as needed. Assume responsibility for investigational product accountability for research protocol purposes and maintain all product related shipments, storage, receipt, and dispensing records. Submit required data to research sponsors and maintain source documentation to support all data submitted to research databases. Interact with monitors on a professional level to resolve EDC queries, submit AE/SAEs they occur per protocol requirement. Ensure all data collected is entered into various EDC systems as required (including, but not limited to iMedidata, Clintrak, Flatiron, Inform) Ensure regulatory compliance when reporting SAEs and/or PDs to the IRBSSr. Clinical Research CoordinatorColumbia, SCObjectiveHealth Research/ Jul 2023 to Dec 2023 Screened subjects from the daily clinic schedule and confirm eligibility of potential study subjects Effectively met deadlines and consistently exceed expectations for timely data collection and submission, as well as exceeding enrollment expectations Ensured inclusion/exclusion criteria are met and that informed consents are obtained for all participants Collected concomitant medications, medical history, and adverse events accurately per ALCOA+ guidelines Request all necessary medical records for Serious Adverse Event reporting in a timely manner Entered source data in EDC and CRIO database as required Work closely with physicians to confirm appropriate treatment for participants per protocol Performed Fibroscans on participants when needed Completed study related clinical assessments such as vital signs, Electrocardiograms, venipuncture, subcutaneous and intramuscular injections Process, prepare and shipped laboratory specimens. Clinical Research CoordinatorWest Columbia, SCPalmetto Retina Center/ Oct 2022 to Jul 2023 Maintained confidentiality and protection of subjects participating in clinical research, ensuring inclusion/exclusion criteria are met and that informed consents were obtained for all participants Coordination of clinical research to ensure activities complied with federal guidelines and institutional policy Recorded data into multiple IwRS and EDC systems (including, but not limited to, Inform, Rave, iMedidata, Clintrak, Zelta and Marvin) Adhere to standards in areas involving data collection, research protocols and regulatory reporting Scribed ocular exams for doctors and confirmed appropriate treatment per protocol Reviewed and resolved data management queries as needed Promptly requested all necessary medical records for Serious Adverse Event reporting to the IRB Accurately collected and recorded all necessary data (e.g., concomitant medications, medical history, adverse events, demographics, etc.) during study visits per ALCOA+ guidelinesClinical Research AssistantWest Columbia, SCPalmetto Retina Center/ May 2012 to Oct 2022 Monitored patient flow for clinical research coordinators and assisted in patient care and management. Accurately collected vital sign measurements per protocol Administered all mandatory questionnaires per protocol Collected, processed and shipped laboratory specimens for analysis per laboratory manuals Performed electrocardiograms, MAIA (microperimetry), manual refractions, and visual fields on subjects when needed Collected and entered all data in the Electronic Data Capture system in a timely manner Ensured clinical research coordinator was aware of any changes to subjects medical history and/or medicationsOphthalmic TechnicianLexington, SCPalmetto Ophthalmology Associates/ Jan 2011 to May 2012 Directed patients to exam rooms for initial evaluations and intake, including history, medications, and symptom documentation, to aide physicians with conducting efficient appointments Operated ophthalmic equipment for patient eye examinations and prepared patients for examinations. Measured intraocular pressure using Goldmann and Tonopen tonometry process Measured and recorded visual acuity and color vision testing Used Lensometer to measure and record lens power of existing prescriptive spectacles.EDUCATION AND TRAININGDiploma Medical AssistingRemington College Sep 2010Columbia, South CarolinaCertificate-PhlebotomyMidlands Technical College Mar 2008West Columbia, South Carolina

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