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Click here or scroll down to respond to this candidateCandidate's Name
Clinical Research ProfessionalResearch Triangle Park, NCPhone: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLELinkedIn: Candidate's Name /Results-oriented and highly experienced Clinical Research Professional with a decade of expertise in coordinating and managing clinical trials. A strong record of optimizing trial processes, including protocol adherence, compliance with regulatory standards, and facilitating successful collaborations between research teams and stakeholders.Work HistorySite Management Associate (2022-2024)ICON, Raleigh, NC, UNITED STATESCoordinated and managed the execution of Phase I III studies, overseeing and ensuring adherence to protocols, data collection, timelines, and regulatory requirements for maintenance and closeout activities.Completed essential document collection and review throughout the study lifecycle inclusive of siteactivation. Organized and managed site clinical TMF documents.Set up and maintained site-related data in applicable clinical systems according to procedures andGuidelines; Performed site level data review and query resolution.Acted as primary site contact/liaison for study and site management issues study-specific addressingquestions, managing study supplies and conducting offsite central monitoring visits/contacts.Performed risk assessment and management responsibilities at the project and site leveland addressed follow up items and issue escalation as needed.Performed all tasks in accordance with ICH-GCP, CRO and Sponsor SOPs, project plans, study-specific processes, database closures and regulatory requirements for US and Canada.Sterile Processing Team Lead (Jun 2021 - Dec 2021)DUKE RALEIGH HOSPITAL, Raleigh, NC, UNITED STATESMaintained SPM database tracking system including but not limited to: updating instrumentation, creatingnew products, updating count sheets; tracking and monitoring tray errors.Managed Daily Needs list for tray inventory, ensuring biological indicator testings was processed and performed in a timely manner.Operating Room Liaison: assisted the Operating Room (OR) staff in prepping suite for surgery by assisting in instrument preparation.Collaborated with OR Team and Central Sterile Department to jointly resolve issues and develop better services for surgical implementation.Provided retraining as needed to other team members as it related to SPM Quality compliance issues and internal audits.Worked closely with Shift Supervisor in other daily activities; orientated and mentored new staff.Certified Sterile Processing Tech Promoted (Nov 2020 - Jun 2021)Provided on-site support for the reprocessing of surgical instruments and trays to contracted facilitiesin compliance with the Department of Health, TJC, OSHA, CDC, AAMI and AORN standards andfacilities goals and policies.Operated all mechanical machinery within sterile processing: cart washers, instrument washers, steam sterilizers, low-temp sterilizers, ultrasonic and drying cabinets.Exceeded in all areas of sterile processing including decontamination, cleaning, assembly, wrapping, sterilization, and storage processes.Completed in-service and company specific trainings offered for growth and developmental advancement.Medical Records Document Imaging Processor (2018-2019)UNC-REX HEALTHCARE, Raleigh, NC, UNITED STATESReviewed records for completeness, accuracy, and compliance within specified regulations.Examined documents for legibility and quality; and evaluate scanned images for patient verification,appropriate chart content, and proper indexing.Identified scanning and indexing errors imploying immediate correction through rescanning of thebatch/image.Protected the safety and security of medical records to ensure that confidentiality is maintained.Clinical Trial Assistant (Dec 2015 Jul 2016)AEROTEK, Raleigh, NC, UNITED STATESWorked with project teams with study-specific administrative tasks: (Report preparation, TMF filing, ISF Binder, and QC reviews, Site document collection/distribution); Designated primary contact for study sites for communications. and document submissions.Performed tracking and management of Case Report Forms (CRFs), queries, and clinical dataflow.Prepared agendas and minutes for internal and project team meetings.Reviewed and tracked site payments and safety information: Aided in the preparation, handling and distribution of Clinical Trial supplies and maintenance of tracking information.Assisted Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with accuratelyupdating and maintaining clinical systems that track site compliance and performance within projecttimelines.Data Management Document Administrator (Mar 2011 - Dec 2016)UCB BIOSCIENCES, Raleigh, NC, UNITED STATESPrepared, reconciled and authenticated data for processing; Adjusted and weighed the data and checked for data inaccuracies.Processed clinical data of 20+ clinical trials. including receipt, entry verification, scanning, uploading, and filing.Maintained compliance of all documents for active and inactive trials; Responded to requests for shipment/receipt of site documents from external storage vendors; Ensured all protocols were adhered to per company SOPs.Performed ongoing checks and quality reviews of TMF data; Communicated discrepancies or findings to Senior Management.Collaborated with Data Managers to manually enter data; scanning and uploading 10,000+ pages in 30days for RDC conversion.Education and CertificationsAssociates of Science, Healthcare Management - Ultimate Medical Academy,Tampa, Florida, UNITED STATESCertified Surgical Instrument Specialist (CSIS), Certification Board for Sterile Processing and Distribution, US AcquiredDate: Nov 2020Certified Sterile Processing and Distribution Technician, Certification Board for Sterile Processing and Distribution, US Acquired Date: Feb 2020Key SkillsCommunication, Problem-solving, Time Management, CTMS, Veeva Vault, RAVE/EDC, PSO, Epic, Data Analysis, MicroSoft Office 365, Logistics and Transportation, Ordering and Shipping, Advarra (IRB/Submissions), and familiarity with other vendor systems. |
