Fnu Joytha

Skills

Patient Recruitment & Pre-Screening, Phone Interviews & Visit Scheduling, Inclusion/Exclusion Criteria Verification, Informed Consent Administration, Patient Data Collection & Organization, Case Report Form (CRF) Verification & Updates, Document Patient Visits & Procedures, Questionnaire Administration & Scoring, Clinical Trials Support, Library/Literature Searches, Regulatory Binders & QA/QC, IRB Submissions, Regulatory Guidelines & Compliance (FDA, ICH-GCP, HIPAA), Formal Data Audits & Compliance Monitoring, Data Preparation & Entry, Records & Electronic Database Maintenance, EHR/EDC Systems, REDCap, CTMS, Electronic Databases, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Windows OS, Attention to Detail, Organizational Skills, Interpersonal & Communication Skills, Accountability, Coordinating Cross-Functional Work

About

Clinical Research professional with an M.S. in Regulatory Affairs and hands-on experience in patient recruitment, informed consent, and regulatory documentation. Skilled in GCP, HIPAA, and EDC systems (REDCap), with a track record of accuracy and accountability across research and regulatory environments.