Highly educated individual with 20 years’ experience in the medical and clinical fields, specializing in clinicalresearch for the past 9 years at the National Cancer Institute (NCI) and National Heart, Lung, and Blood Institute. Launch a new monitoring program at NHLBI, established monitoring SOPs aligned with NHLBI/DIR requirements, assess workload and prioritization of the NHLBI studies, developed study customized monitoring plan, developed monitoring schedule and distribute the work within the monitoring team, established training program for new CRAs.Possesses additional technical background to design, support, and implement C3D and Medidata Rave databases, Case Report Forms (CRFs) development and maintains ensuring accuracy and validity of CRFs and the database.Participate in writing draft of proposal for other contracts, incorporating specific client requirements into standard format used for previous engagements. Prepare high quality reports including graphs, tables, drafts of written memos and correspondence. Organize materials prepared during engagement and ensure that work papers are properly filed and stored for the future access. Evaluate and recommend system improvements and new tools and technologies to Harris, NCI/CCR and NHLBI/DO management.Manage technical support to IRB database, iRIS, the protocol lifecycle tool for Scientific Review and IRB processing.Provide support to CRO related activities via CDR (Central Data Registry), the single integrated database used to register, randomize, track and report on all human subject protocols at the NCI/CCR.Evaluation, implementation, and customization of analytical applications such as I-Review and Science Analysis System (SAS).Regular formal training for contract and customer on electronic clinical database and reporting tools.

Continue to assist NHLBI DIR Principal Investigators and DIR clinical research staff with guidance on Good Clinical practice, quality assurance adults, DIR Sponsor & Investigator clinical research monitoring and study specific monitoring• Provide site coordination, management, and performance monitoring (including documentation) of in-houseand on-site activities (all types of visits such as initiation, monitoring, close out, audit, etc.) for single and/ormulti-investigational sites in accordance with designated project assignments (including applicable SOPs,ICH, GCP, and applicable international/national regulatory requirements)

• Provide site coordination, management, and performance monitoring (including documentation) of in-houseand on-site activities (all types of visits such as initiation, monitoring, close out, audit, etc.) for single and/orResearch, analyze, plan, and coordinate data base design, development, implementation, maintenance, anduser support of clinical data base systems

Worked in a diverse clinical research environment providing data management support for Phases I, II, andIII clinical trials.• Abstracted data from source documents as needed, understood laboratory and diagnostic results to access andmonitor toxicities, evaluated tumor responses, and managed patient and protocol information• Performed duties of abstraction and entry of study data into clinical database to process, track, and validatedata along with data processing and entry instructions

Assisted doctors to examine and treat patients• Responsible for collection of patient’s medical history and performance of laboratory tests• Guided patients on medicines and treatment at home• Administered patients’ injections and took electrocardiograms as needed

Scheduled appointments, kept records, received payments from patients, and ordered supplies• Prepared patients for dentist’s examination, handing the dentist the proper materials and tools• Operated X-ray machines, sterilized instruments, and mixed compounds for cleaning or filling teeth