Nijah R. Staine
Phone: 646-***-****
Email: ******.******@*****.***
EDUCATION
University of Phoenix Phoenix, AZ
Bachelor’s Degree in Health Administration
TECHNICAL SKILLS
MedDRA, WHODD, Medidata Coder and Rave; Veeva Coder and Veeva EDC, Netsmart/Meditech
(EMR System), Microsoft software applications
EMPLOYMENT
Nov 2021 -present Lumos (on assignment to Hire-a-med, Inc) Remote, USA Drug Safety Consultant
• Coding using MedDRA and WHODD of AEs, SAEs, MH, procedures, concomitant medications etc in Veeva Coder
• Issuing and closing queries in EDC
• Ensuring timely reporting of SAEs/AEs to the Regulatory Authorities, and cross-reporting to pharmaceutical partner(s
• Ensuring consistent coding across studies
• Preparing clinical narrative summaries daily for AE reports from clinical studies and spontaneous, post-marketing reports and formulates follow-up information requests
• Following GCP principles to ensure all medical coding activities while following SOPs and associated guidelines Jan 2019- Nov 2021 Clovis Oncology (on assignment to Hire-a-med, Inc) Remote, USA PV/Safety Associate/Contractor
• Prepared of narrative, assess labeling, execute QC on key fields of data entry
• Developed, prepare and edit follow-up letters
• Issued queries internally and externally to clarify ambiguous terms and data discrepancies
• Reviewed medical record follow up to cases in litigation in accordance with US FDA Regulations
• Executed case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality, also updated narrative if needed Mar 2015- Nov 2018 Calvary Hospital (Hospice) New York, NY Medical Records/ Data Entry /Coordinator
• Entered customer and account data from source documents within time limits
• Compiled, verified accuracy and sorted information to prepare source data for computer entry
• Reviewed data for deficiencies or errors, corrected any incompatibilities and checked output
• Prepared patient charts and gathered information and documents from patients
• Ensured that the medical records are organized, accurate and complete
• Created digital copies of paperwork and storing the records electronically
• Filed the paperwork and reports of patients quickly and accurately
• Safeguarded patient records and ensured that everyone complies with the HIPAA standards
• Transferred data into the facility’s main system database
• Processed the records for admitting and discharging patients Jun 2011- Jan 2015 Dr. Wing Tsang New York, NY
Medical Assistant
• Performed general office duties such as answered telephones, took dictation or completed insurance forms
• Prepared treatment rooms for patient examinations, keeping the rooms neat and clean
• Recorded patients' medical history, vital statistics and information such as test results in medical records
• Collect blood, tissue or other laboratory specimens, log the specimens, and prepare them for testing
• Greeted and logged in patients arriving at office or clinic
• Scheduled appointments for patients
• Operatde x-ray, electrocardiogram (EKG), and other equipment to administer routine diagnostic tests
• Performed routine laboratory tests and sample analyses
• Interviewed patients to obtain medical information and measure their vital signs, weight, and height
• Helped physicians examine and treat patients, handed them instruments and materials or performed such tasks as giving injections or removing sutures
• Contacted medical facilities or departments to schedule patients for tests or admission REFERENCES: Furnished upon request.