Detail oriented team player with strong organizational and communication skills, who is self-motivated, performs well under pressure, and easily adapts to changes within organizations. Looking for an opportunity to utilize my skills and experience and make a positive impact within a company.
WRITERESULT, Cranford, NJ
Clinical Data Coordinator 2010-Present
Proofread and verity clinical data comparing associated images in EXPEDATA and patient information from sponsor, exercising SOP's accordingly. Log any issues into Excel in order to keep track and follow procedures as necessary.
• Resolving queries with the assistance of the study sponsor, updating database, recording all study sponsor adverse events, committing forms, correcting discrepancies found during database quality control reviews, and completing any required database lock preparations.
• Noting any discrepancies found when comparing database listings, reports, and files with the associated images, query anomaly reports, and associated query anomaly report entries.
• Follow clearly defined and controlled processes utilizing GMP to ensure consistency and compliance within FDA and the clients' specifications. Record and safeguard study data in accordance with ISO standards to guarantee data confidentiality, integrity and availability.
- Clinical Data Coordinator at WRITERESULT
- Customer Service at RICOH CORP., W
- Customs Coordinator at BDP INTERNATIONAL
- Customs Coordinator at FOOTSTAR INC
9 years at this Job
• Accurately and proficiently entered data using the electronic data capturing system, OpenClinica
• Redacting sensitive patient information
• Actively participated in debrief meetings, to ensure adherence to study specific data entry guidelines.
• Performed Quality Control on patient data as needed.
• Reviewed patient listings as needed.
• File and archive data as needed.
• Perform other functions when need arises: MDR creation, Combining patient files, and
• extracting patient files.
- Clinical Data Coordinator at Musculoskeletal Clinical Regulatory Advisers via inVentiv Health
1 year, 9 months at this Job
- MSc. - Data and Network Security
- BSc. - Computer Science /Mathematics
Analyze and evaluate clinical data terminology (medical history verbatim, adverse experiences and/or concomitant medications) for coding purposes Recognize and initiate resolution of data inconsistencies with subsequent follow-up until satisfactory resolution Ensure medical accuracy, consistency and integrity of the dictionary system by concise coding by thorough term/drug research and definition Create/maintain ad-hoc computer procedures utilized in generating subset dictionary listings for sponsor review and approval Demonstrate initiative and ability to work under pressure to organize work requests and set priorities as defined by sponsor driven project milestone deadlines. Maintain Clinical Data Management SOPs Clinical Data Management contact for coding related questions and/or query resolutions Sponsor contact for study related questions and/or query resolutions Licensed Massage Therapist Private Practice - Phoenixville, PA April 2017 to Present Swedish, Deep Tissue and Therapeutic massage in my home or mobile location
- Clinical Data Coordinator at PRA Health Sciences
- Project Manager for Customer Quality Triage Intake Team at DePuy Synthes Companies of Johnson and Johnson
- Customer Quality Specialist III at ACAC
- Safety Manager at Quality Data Services
5 months at this Job
- B.S. in Health Science - Health Science
Duties: Assist in the conduct and implementation of oncology research studies. Participate in the initiation, monitoring, completion, & reporting of routine to moderately complex clinical studies. Assist Clinical Research Specialists and the Principal Investigator in the conduct and implementation of clinical research. Consent patients, data collection, data entry, follow up, and maintain regulatory documents.
- Clinical Research Specialist/ Clinical Data Coordinator at IU SCHOOL OF MEDICINE, Simon Cancer Center Clinical Trials Office
- Senior Clinical Study Assistant at IU SCHOOL OF MEDICINE, Endocrinology Research
- Medical Assistant at IU Health, Cancer Pavilion
- Bilingual Medical Assistant at Community Physician Network
1 year, 7 months at this Job
- Bachelor of Science, Business - Healthcare Management
- Associate of Applied Science - Medical Assisting
Responsibilities: Review data for discrepancies via edits or manual review, generate queries, address queries. Create reports for in-house purposes and sponsor specific purposes. SAE reconciliation, external Reconciliation, created external Edit checks, aided in review of guidelines and any other documents that needed/needs review.
- Clinical Data Coordinator II at Covance
- External Data Specialist I at Chiltern
- Clinical Data Coordinator II at ICON Clinical Research
- Lab Specialist (temp) at ICON Clinical Research
2 years, 10 months at this Job
- BAchelor of Science - Environmental Studies
• Conduct medical record data management and data entry with Epic Systems and REDCap (Research Electronic Data Capture) for analysis and research, administering a database with 1000+ entries
• Demonstrate ability to learn new systems quickly and be detail-oriented, organized, accurate, and analytical when working with multiple systems and spreadsheets simultaneously to abstract different variables of data
• Familiar with HIPAA compliances, Good Clinical Practice guidelines, confidentiality, and medical terminology
- Clinical Data Coordinator, Moores Cancer Center at UC San Diego Health
- Student Health Advocate - Alcohol and Other Drugs at UCSD Health Promotion Services
- Client Services Intern, Health Nucleus at Human Longevity, Inc
- Events/Office Assistant at California Institute of Telecommunications and Information Technology
10 months at this Job
- Bachelor of Science - Public Health, Business
Lead Phase I Hematology/Oncology Clinical Data Coordinator, December 2014 - Present
• Work with complex computerized records systems and maintain security and integrity.
• Collect data from clinical trials.
• Sort information and ensure it is screened, grouped, summarized, transcribed, and coded.
• Consult with other coordinators to solve operational or data problems.
• Prioritize work in line with project management decisions.
• Manage clinical trials through review, computerization, cleaning of clinical data and databases in compliance with standard operating procedures and regulatory agency guidelines.
• Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
• Resolve data queries and inconsistencies and revise case report forms in compliance with SOP's
• Implement strategy for data cleaning and the design and programming of clinical databases.
• Review and approve design, data review ground rules and database design according to SOP's and protocol.
• Assist with preparation and follow up for internal, sponsor, and FDA audits
• Train new data coordinators
- Lead Phase I Hematology/Oncology Clinical Data Coordinator at University of Miami Sylvester Comprehensive Cancer Center - Clinical Research Services
- Research Technician at Duke University Medical Center Department of Neurology - Dr. Ornit Chiba-Falek Lab
- Research Technician at NOAA CLIVAR A16 Cruise - Dr. Frank Millero Lab
- Research Assistant at University of Miami Biology Department - Dr. Akira Chiba Lab
4 years, 1 month at this Job
- Bachelor of Science - Biology and Marine Science
• Perform all data management deliverables for assigned studies
• Define edit checks to be programmed for the study/project
• Create DMPs
• Maintenance of TMFs
- Clinical Data Coordinator at Amarex
- Clinical Data Associate at Covance Pharmaceutical Research and Development Co. Ltd
- Junior Statistical Programmer at Covance Pharmaceutical Research and Development Co. Ltd
- Intern at Zurich North America
2 months at this Job
- Bachelor's - Applied Mathematics
➢ Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
➢ Perform query management including review, creation and resolution.
➢ Communicated with cross functional groups throughout the project lifecycle.
➢ Work extensively on laboratory data reconciliation including lab specimen tracking.
➢ Work extensively on manual and Statistical Analysis System (SAS) data listings.
➢ Interacted with internal and external stakeholders regarding study activities.
➢ Maintain quality control of the data, project deliverables and closeouts.
➢ Assist in reviewing medical coding for validity and completeness, as needed.
➢ Provide reports to the clinical scientists and clinical data management (CDM) team as dictated by project requirements.
➢ Interacted with study sites and vendors.
➢ Assist with tracking of project status and task completion. Report and discuss data findings with clinical scientists and senior clinical data managers.
➢ Performed study close out cleaning activities.
➢ Attend and lead internal and external project meetings. Ensure assigned tasks are completed within the required timeframe.
➢ Provided project status reports and study timelines to the upper management.
➢ Responsible for project data management deliverables.
➢ Be a resource to CDM and clinical scientists' team for questions and guidance related to lab clinical data.
➢ Work on Medidata RAVE and InForm.
- Clinical Data Coordinator/Clinical Data Manager at PRA Health Sciences
- Clinical Data Coordinator II/Analyst at Imaging Endpoints
- Clinical Data Analyst at Statistics & Data Corporation
- Study Manager at Southwest Clinical Research
2 years, 1 month at this Job
- MS - Bioinformatics
- BS - Biotechnology
Participated as contract member on global teams for two studies - Colorectal Cancer Study and Cardiac Study utilizing Medidata Rave for CRF manual page review, issuing queries, resolving queries and freezing forms.
- Contract Clinical Data Coordinator I at COVANCE, INC
- Contract Clinical Data Manager/Research Associate at AMERICAN COLLEGE OF RADIOLOGY
- Clinical Data Analyst at PHARMANET
- Clinical Data Manager at BIOCLINICA, Inc
9 months at this Job
- B.S. - Medical Technology
- - clinical
- - FDA Law