Description
Primary Responsibilities:- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Assist with protocol development and study report completion
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
- Assure regulatory compliance of investigational sites with company SOPs and FDA and ICH guidelines
- Ensures trial master file is current and maintained
- Provide guidance, direction, and management to CRAs
Skills / Education Requirements:
- BA/BS, nursing degree, or advanced degree. Life sciences preferred
- 5+ years relevant experience as a clinical trial manager or lead CRA
- Must be available to travel up to 50%
- Excellent verbal and written communication skills in English
- Experience managing Oncology or CNS clinical trials preferred
- Proficiency with MS Office applications
To find out more about Real please visit www.realstaffing.com