Ajah Washington

Reviewing protocol submissions for completeness and communicating with researchers to correct deficiencies as it relates to completeness

• Reviewing entries in the CTMS electronic systems (eProst, Velos, Complion, etc.)
• Performing data entry and quality control of documents for 9 studies and multiple sites for each study
• Development of Sponsor eTMF Reference document, maintenance of Sponsor eTMF (Electronic Trial Master Files), and ISF (Investigator Site Files)
• Creation of reference documents needed for regulatory management such as; essential document tracker, FDA submission document tracker, eTMF and ISF (Investigator Site File) binder setup tracker, etc
• Collection and review of regulatory study trial documents for study start-up, maintenance, and close-out
• Understanding of current federal regulations, guidance documents such as ICH GCP guidelines, and state laws
• Tracking the progress of clinical trial subject recruitment, trial supplies & documentation
• Managing & tracking FDA submissions and approvals
• Tracking completion and submission of the eCRF (Electronic Case Report Form)
• Develops regularly updated project tracking tools & systems
• Responsible for study maintenance & filing of study administrative files
• Planning and organizing study-specific meetings, along with distribution of agendas, meeting minutes, and study updates
• Managing effective communication with study teams
• Participating in special projects to continuously improve the management of trials by creating new; processes, tools, systems, SOPs, and organizational tools
• Maintenance of all site information including; contracts, budgets, and reports
• Facilitating tracking of invoices & authorized clinical trial payments to selected vendors and investigational sites, accurately and promptly
• Ensuring proper maintenance and documentation regarding site management, and quality control of regulatory documents and credentials.

• Responsible for overseeing testing of COVID-19 samples using molecular biology testing automation machinery - Amplitude
• Responsible for observing laboratory technicians initiation, maintenance, and overall knowledge of Amplitude
• Ensuring quality control in all pretesting & post testing mechanisms
• Navigating results, extracting and sharing data to specific parties while following HIPPA
• Operating, maintaining, and troubleshooting minor errors on Amplitude and other related machinery
• Oversee machinery daily maintenance to ensure proper functioning & quality use of Amplitude
• Adhering & following CLIA guidelines & COLA requirements
• Communicating with Field Service Agent and Customer Service Manager on any system errors
• Ability to analyze data in QuantStudio to determine whether COVID-19 is detected
• Ensuring quality control in all testing mechanisms.

• Responsible for testing COVID-19 samples using molecular biology mechanisms
• Ensuring proper use of all laboratory equipment
• Training incoming laboratory technicians
• Implementing quality control spreadsheets to ensure testing accuracy
• Creating sample plates containing bacteriophage and protein kinase in order to run samples
• Following HIPAA & privacy guidelines
• Accessing & Navigating APOLLO (LIMS) in order to effectively manage samples & associated data
• Ensuring quality control in all testing mechanisms.

• Responsible for testing COVID-19 samples using molecular biology testing laboratory automation machinery - Abbott2000, Qiagen, Cephaheid
• Responsible for running, maintaining, and analyzing laboratory operations
• Daily machinery maintenance to ensure proper functioning
• Ensuring proper use of all laboratory equipment & laboratory machinery
• Data recording
• Setting up & analyzing RNA extraction & PCR
• Analyzing data from QPCR to determine whether COVID-19 is detected
• Releasing data results to proper departments
• Following HIPAA & privacy guidelines
• Ensuring quality control in all testing mechanisms.

• Responsible for administering medication to 40+ residents at properly scheduled time
• Creating, leading, and presenting monthly PowerPoint presentations for our Alzheimer's department
• Updating patient profile when prescribed for new medicine to ensure accuracy
• Organization of medical charts, following HIPPA & FDA regulations
• Accurately documenting empty medication inventory for pick up
• Supervision of up to 6 Certified Nursing Assistants, delegating tasks and ensuring organization throughout day
• Managing intake of medication ensuring accurate amount
• Managing & organizing distribution of medication into proper locations, separated by room number and name.

• Objective: To obtain a soil sample and determine whether this sample contains bacteria that creates antibodies
• Conducted scientific research project on the protein ATP5F1A and its process in prostate cancer
• Developed and produced scientific manuscript with an informative abstract
• Analysis of Protein
• Produced protocol for laboratory methods used without supervision
• Isolated, extracted, and amplified DNA using scientific techniques
• Amplified DNA using PCR and Gel Electrophoresis
• Collected and analyzed data to determine the molecular process of this protein.

• Objective: To obtain a soil sample and determine whether this sample contains bacteria that creates antibodies
• Performed various tissue culturing techniques
• Isolation of bacteria and analysis of different bacterial strands
• Performed cell passaging techniques
• Performed culture analysis on bacteria
• Performed serial dilutions and numerous scientific molecular techniques
• Prepared control and experimental media
• Compared bacterial growth on the different types of agar
• Utilized proper aseptic techniques in laboratory setting.