Clinical Research Coordinator
Resume:
Courtney
Sease
********@*****.***
SUMMARY
A 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.
SKILLS
Lexington, SC 29073 • IRB
• Microsoft Office
• Communication Skills
• Compliance
• Clinical Research
• Detailed Oriented
EXPERIENCE
• Data analysis
• Good Clinical Practice
• Scheduling Proficiency
• Phlebotomy
• Specimen Handling
• Research Experience
Clinical Research Coordinator
Orangeburg, SC
SC 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 IRB
S
Sr. Clinical Research Coordinator
Columbia, SC
ObjectiveHealth 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 Coordinator
West Columbia, SC
Palmetto 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+ guidelines
Clinical Research Assistant
West Columbia, SC
Palmetto 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 subject’s medical history and/or medications
Ophthalmic Technician
Lexington, SC
Palmetto 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 TRAINING
Diploma— Medical Assisting
Remington College Sep 2010
Columbia, South Carolina
Certificate-Phlebotomy
Midlands Technical College Mar 2008
West Columbia, South Carolina
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