Dedicated Senior Clinical Research Associate with more than 6 years of experience. Broad background in clinical trials management of phase I/II/III trials in various indications including the implementation of study protocols, monitoring of sites and on-site data management and collection. Significant expertise in managing good relationship with the site to aid success of the study.
PROFESSIONAL SKILLS SUMMARY
Strong attention to detail with solid knowledge of GCP, ICH, FDA and other federal regulations.
Excellent interpersonal, presentation, written and communication skills.
Sound knowledge of human subject protection regulations, and general clinical research process.
Have a full understanding of AE/SAE reporting procedures, productions of reports, narratives and follow up of AE/SAEs.
Very familiar with medical terminology and clinical research concepts.
Multitasking: strong ability to work on several projects
Experienced using Electronic Data Capture (EDC), Interactive Voice
Response Systems (IVRS) and Clinical Trial Management Systems (CTMS).
Strong Clinical Trial Computer Software experience including but not
limited to Microsoft Office (Word, Excel and Power Point).