Motivated and ambitious Certified Clinical Research Professional with more than 20+ years dedicated to Oncology clinical trial research. Accomplished in the management and daily operation of Phase I-III clinical research trials, ensuring patient safety, protocol compliance and quality data. Supervised research-related activities at participating network sites, including site assessments, initiation meetings and training of site personnel. Mentored many junior research associates and coordinators. Active contributor to the development of protocols and related source documents. Prepared consent forms, CRFs, source worksheets and spreadsheets capturing trial data. Assessed subjects for adverse events per study parameters and protocol time points. Reported ADRs/SAEs to appropriate agencies, including FDA, NCI, pharmaceutical sponsors, and IRB. Knowledgeable in completion of FDA Form3500a for mandatory reporting of AEs/SAEs involving IND/IDE agents. Co-authored seven (7) scientific journal publications. Competent with multiple computer applications, MS Word, Outlook, PowerPoint, and Excel. Proficient user of multiple Electronic Data Capture (EDC) systems. Merited favorable findings in FDA audits, multiple NCI audits and Cooperative group audits. Awarded Certified Tumor Registrar (CTR) accreditation from NCRA 9/1995. Awarded CCRP accreditation from SoCRA 10/2002. Ability to work independently & in team setting. Excellent verbal and written communication, organizational and decision-making skills. Developed QA/QC and SOP processes designed to improve quality, accuracy, and timely submission of data. Strong planner and problem solver who readily adapts to change, able to work independently and in team setting.

Highlights:

• Team Player
• Cancer
• Compliance
• Audit
• Clinical Research
• Medical
• Medical Transcriptionist
• Pathology
• Pharmaceutical
• Protocol