10+ years of proficient experience into clinical research as a Clinical research associate in pharmaceutical industries and clinical research organizations. * In-house and regional monitoring experience in Phase I, II, & III. * Capable to work as both in-house CRA and as a Regional CRA with efficiency to monitor and manage any number of sites depending on Sponsor's SOP. * Good working knowledge of GCP and ICH guidelines. (cont.) * Excellent understanding and ability to attain and maintain a working knowledge of GCPs and applicable SOPs. * Excellent understanding of medical terminology. * Effective clinical monitoring skills that include conduction of qualification, initiation, monitoring, and close out visits. * Proficient in tracking serious adverse event safety reports to ensure compliance. * Capable of reviewing the CRF forms for completion and correction according to sponsor's policy. * Expertise in evaluating and selecting potential investigators who can proficiently conduct the clinical trials. * Expertise in filing clinical Trial master file. * Proactively identify solutions when issues arise and resolve by using well-developed problem-solving skills.

Highlights:

• Research
• Clinical Research
• Management
• Quality
• Quality Assurance
• Quality Control
• Audit
• Oracle
• Filing
• Good Clinical Practices