Description
- 3 clinical research studies while developing an understanding of the drug development process Good Clinical Practices and relevant regulations. Perform management of study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). New experience oncology trials (lung cancer melanoma antigen-specific immune-therapeutics) RDE (electronic CRF system used by GSK Biologicals) SBIR (internet randomization system used by GSK Biologicals) - 3 clinical research studies while developing an understanding of the drug development process Good Clinical Practices and relevant regulations. Performed management of study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). New experience oncology trials (breast renal cell carcinoma) electronic CRFs (InForm) - 4 clinical research studies while developing an understanding of the drug development process Good Clinical Practices and relevant regulations. Provided clinical and technical support for CRA I and administrative staff. Performed management of study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). Therapeutic experience Rheumatoid Arthritis Crohn's Disease Diarrhea - Associated Irritable Bowel Syndrome