Description
Essential Duties and Responsibilities:- Supervise and mentor junior CRAs and other operational personnel
- Work with the medical monitor to develop protocols and all documents required to initiate and conduct clinical studies, including informed consent forms, investigator brochures, case report forms, study procedure manuals, etc
- Select and manage external service providers
- Develop and manage the clinical project team to meet clinical trial timelines consistent with the company's goals
- Select study investigators and evaluate adequacy to perform research and meet study timelines
- Manage studies to meet enrollment goals
Requirements:
- Bachelor's degree plus 6 or more years of pharmaceutical clinical research experience; RN degree or a degree in a healthcare related field or the life sciences is desirable but not mandatory
- Relevant experience in clinical trial execution
- Multinational Phase 2 experience is a plus and highly desired
- Oncology experience
- Strong knowledge of GCP and ICH guidelines
- Must be willing to travel as required for the project; estimated travel ~25-30%
To find out more about Real please visit www.realstaffing.com