C O. Email & Phone Number

New York City Metropolitan Area

Dallas/Fort Worth Area

Sherman/Denison, Texas Area

Edison, Nj

• In-depth knowledge of regulatory documents- IND, NDA, protocols, contracts and budgeting, financial disclosure forms, protocols, Form 1572• Trained on ICH-GCP guidelines, HIPAA and FDA regulations.• Knowledge of all phases of clinical trials- phase1, phase 2, phase 3 and post-marketing phase-4 and conducting them in accordance with SOPs.• Coordinated and tracked the progress of four different study projects, conducted in-house monitoring• Generated timely and accurate Site Qualification, Site Initiation, Site Monitoring, and Site Closeout reports in the CTMS system (Clinical Conductor)• Uploaded trial documents in eTMF (master Control) and collaborated during the lifecycle of the product• Conducted data entry, discrepancy review and data resolution in the EDC system (OC-RDC)• Assisted with preparation of Investigator’s Brochure, Clinical Trial Protocol, Informed consent form, and regulatory submissions for IND and NDA applications• Communicated with Principal Investigators and Research Coordinators providing remote monitoring support to ensure site compliance with clinical trial protocol procedures• Gained proficiency in US FDA/ICH/GCP regulatory requirements and IRB functions, HIPAA, Trial Design, Clinical Trial Phases, Site Selection, Site Management, Site Initiation, and Closeout• Attained deep understanding of Risk-Based Monitoring, Evidence-Based Medicine and Personalized MedicineHands on experience in therapeutic areas as Neurology, Oncology, Immunology

Greater Nashville Area, Tn

• Assisted nurses and technicians with sign on procedures including creating patients list, adding and removing patients and customizing specific tool bars. • Trained nurses on how to navigate the system during admission, discharge and transfer (ADT) documentation.• Assisted all users on how to document education and care plan for each patient, correctly document medication administration and update patient flowsheet.

Bachelor'S Degree, Computer Science

Advance Certificate In Clinical Research And Management, Clinical Research