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Click here or scroll down to respond to this candidateCandidate's Name
Alexandria, VAEMAIL AVAILABLE 727.637.1472 http://LINKEDIN LINK AVAILABLE Accomplished Clinical Research professional with a 15+ year career dedicated to advancing clinical research and driving positive patient outcome. Particular expertise in Central Monitoring and Data Management for clinical trials. Combines advanced analytical and technical skills to manage complex projects and provide innovative solutions that ensure smooth progression of clinical trials with the highest level of data accuracy and quality. Applies exceptional communication, mentoring, and leadership skills to inspire and motivate clinical teams. Promotes a collaborative, goal oriented environment of technical excellence. Utilizes deep knowledge of cancer staging procedures, treatment protocols and guidelines to ensure quality and accuracy in all aspects of data management. AREAS OF EXPERTISEOncology Clinical Trials ManagementTherapeutic Area Oncology :specializing in GYN, GI, GU, and Melanoma/Sarcoma Clinical Data Management: collection, extraction, abstraction, analysis, central monitoring, plans, audits, discrepancies, validation, data transfer, deliverables Data Quality: data accuracy, QA/QC,QAR Team leadership: training, mentoring Query: writing, response, review, discrepancies, resolution, integration Study site: collaboration, monitoring, training Project Management Patient Screening Protocols, SOPs, Regulations, Compliance Government Contracts Reporting/Documenting Presentations PROFESSIONAL EXPERIENCEClinical Research Coordinator II August 2019-Present Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD Clinical Research Coordinator (CRC) II for the Gynecologic Cancer Center of Excellence Program at the Womens Health Integrated Research Center (WHIRC), Annandale, VA. Since 2022, a primary contributor to the WHIRC program, overseeing small and large, multi-site clinical projects supporting a TDAN research protocol and translational research studies across the GYN-COE program. As a senior team member, coordinates research activities as the principal site-data quality reviewer and trainer for new team members of the internal Clinical Research Team; provides guidance across five healthcare facilities. Collaborates with healthcare sites to provide training, enhance recruitment, expedite resolution of queries, implement priorities, execute corrective action plans, and launch new initiatives. Delivers preliminary training in EMR use for retrieval of data and in abstracting data to CRF; provides extended training in reading and interpreting critical data, including imaging, CLIA, OP reports, and pathology reports. Conducts programmatic Quality Assurance Reviews, providing feedback to optimize the quality of research data; offers recommendations for improvement to the Program Manager and provides tailored training. Supports the development and implementation of systems and technologies to optimize data flow and data status reporting; develops and strengthens multiple SOPs, training materials, and workflow checklists. Reviews patient data; performs data checks and conducts programmatic Quality Assurance Reviews to correct inconsistencies and errors in the CRF; issues and resolves queries while developing and maintaining accurate and up to date source documents. Organizes and manages longitudinal cancer procedures, treatments, biomarkers, CLIA genetic testing collection, and follow up data while overseeing clinical datasets for translational investigations; tracks, summarizes, and provides updates on contribution and activities. Proficiently handles data exports, abstraction, reviews, summarization and organization from medical records demonstrating advanced competency across various electronic health record systems. Collaborates on clinical verification of tumor tissue biobanking for a special cohort, coordinating data requirements with assay labs for accurate and compliant data collection based on specifications. Upgrades, harmonizes, and credentials research records to align with different disease classification, staging, and grading editions, versions, and systems; classifies disease distribution, residual disease, and pathogenic alternations. Generates and presents monthly status reports for collaborating facilities; prepares and distributes data reports and extracts; contributes to abstracts, presentations, and manuscripts as needed. Page 2 of 3 Candidate's Name (727) 637-1472 EMAIL AVAILABLE Clinical Data Manager/Abstractor II August 2015- June 2019 Peraton, Inc., Alexandria, VA Abstracted clinical data related to eye injuries and diseases from various Department of Defense (DOD) data sources; entered abstracted data into the Defense and Veterans eye injury Registry (DVEIVR). Reconstructed antiquated database of 10K+ cases; ensured security of the database from breaches and losses. Assisted program leadership and management in coordination, production, and weekly distribution of data reports, extracts, and other deliverables for special projects. Performed self-audits and peer reviews for regulatory compliance and verification of complete, accurate data abstraction, utilizing medical and clinical knowledge and sound judgment. Ensured compliance with patient privacy and security regulations, including HIPAA and the HITECH Act. Clinical Data Manager May 2008-July 2015Orlando Health/MD Anderson Cancer Center, Orlando, FL Supported data management efforts for Phase I, II, III Oncology Clinical Trials, managing as many as ten protocols simultaneously. Assisted the Clinical Research Coordinator; ensured proper collection of data for study eligibility and procedures; performed comprehensive data management, integrating all query responses in clinical databases. Participated in initiation visits and investigator meetings; implemented and tracked progress of clinical trials in accordance with project timelines, budgets, and quality expectations. Efficiently and accurately reported research data to the studys respective sponsors, utilizing EDC. Executed database validation, discrepancy management, query resolution of data in compliance with SOPs. Performed data entry, database audits, and coordinated schedules for follow-up research studies. . Followed informed consent processes and maintained records including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs. Oversaw the regulatory and legal requirements of the complex portfolio; applied deep knowledge of all phases of clinical trial research to ensure compliance in data collection, handling, and processing in compliance with regulatory standards and FDA guidelines, including ISO, FDA, GCP/ICH, SDTM, and 21 CFR Part 1. Personally screened patients for eligibility, collected and analyzed recruitment data; determined patient commitment and obtained informed consent; educated patients in the research protocol; complied with all protocols GCP.Corporate Health Information Analyst May 2005-May 2008 Orlando Health/MD Anderson Cancer Center, Orlando, FL Analyzed and monitored patient records; retrieved, copied, and delivered medical files and microfilm records in response to staff requests; performed electronic chart constructions for patients legal documentation. Assisted physicians with completion of medical record deficiencies in compliance with JCAHO and state 30- day post discharge regulations. Maintained departmental records, using a complex electronic filing system to retrieve, merge, update records, enter new information, locate missing records, and purge outdated records. Health Information Technician III August 2001-June 2003 St. Lukess Medical Center, Kansas, City, MOPage 3 of 3 Candidate's Name (727) 637-1472 EMAIL AVAILABLE EDUCATION TECHNICAL SKILLS CERTIFICATIONSBachelor of Science in Health Information Management University of Central Florida April 2007 Technology:Electronic Health Record (EHR): AHLTA, TMDS, JLV, HIMS GE Centricity, Mosaiq Citrix, Sovera, Epic, Sunrise XA (CIS); Athenahealth; DVEIER (Defense and Veterans Eye Injury Registry) Electronic Data Capture (EDC) tools: Clinical Data Manager, Oracle Clinical RDC Medidata: RAVE, INFORM, MARVIN, REDCapMS Office Suite WordPress Zoom MS Teams CTMS (Clinical Trial Management System) Compliance: Deep knowledge of U.S. government, DOD, VA security standards, guidelines, effective applications FDA regulatory standards CDISC, SDTM, CDASH, CFR 21 part 1 ICH/GPC HIPPA HITECH Act Certifications (current): CLTI - NIH Human Subject, CPR, ICH Good clinical Practice (GCP), HIPPA, Blood Borne Pathogens (BBP)Public Trust Security ClearanceLanguages: Bilingual, Amharic/English Certified Amharic Interpreter VOLUNTEER SERVICE & AFFILIATIONSSOCRA (Society of Clinical Research Associates) 2008-Present Assistant Coach Springfield South County Youth Club September 2019 - Present Plans, organizes, and directs the youth volleyball program providing group and individual instruction in volleyball technique.to student athletes Organizes and executes effective team practice and coaching for players; assess players skills and assigns team positions.Medical Interpreter (Amharic) April 2018-Present Conducts in person and by phone English medical and general interpreting for medical providers, patients and/or their family members to Amharic speakers. |
