HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety on pharmaceutical products and devices * Strong knowledge in global regulatory reporting requirements on adverse event reporting. * Source data/document verification (SDV) * Case processing of AEs and SAEs from global post-marketing and clinical study reports * AE reporting, coding guidelines and SAE reconciliation * Excellent working knowledge of EDCs * Proficiency in reviewing protocol compliance, focusing on inclusion/exclusion requirements * Ability to understand, extract and analyze information from medical records. * Highly detail-oriented, with superior record retention and time management skills. * Ready and willing to accommodate frequent local, domestic or international business travels. THERAPEUTIC AREAS: * Oncology: Prostate, Lung, Ependymoma, Colon, Solid tumors * Cardiovascular: Congestive Heart Failure, Essential Hypertension * Infectious Disease: HIV/AIDS

Highlights:

• Direct Patient Care
• DRESSING CHANGES
• Medical
• Patient Care
• Suctioning
• Surgical
• Wound Care
• Acquired Immune Deficiency Syndrome (AIDS)
• HIV
• Monitoring