Description
Main Responsibilities:Manage all aspects of clinical studies to ensure they are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH / GCP guidelines. Planning, implementing, monitoring and management of tracking clinical trials either directly or through the CRO (Contract Research Organization). Assist in the management of CROs and other study-related vendors. Coordinate cross-functional components of the clinical trials process. Participate in the design and development of clinical trial protocols and Case Report Forms. Work with data management to resolve data discrepancies. Prepare clinical study reports and annual reports.
Experience Required:
Must have 5-8 years experience in clinical development including experience managing junior CRAs and CROs. Knowledge of FDA regulatory requirements and ICH/GCP guidelines. Knowledge of drug product supply requirements. Proficiency in monitoring clinical trials and managing clinical sites. Proficient in Excel, Word, and PowerPoint. Excellent written and verbal communication skills. Ability to multi-task, prioritize, and work well in a fast paced environment.
Education: Bachelor's degree in scientific discipline or other health-related field, or RN degree.
To find out more about Real please visit www.realstaffing.com