Description
Roles and Responsibilities:- Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
- Develop and maintain good working relationships with investigators and study staff
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Track and report on progress of study including site activation, patient enrollment, monitoring visits
- Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
- Assist in identification and hiring of appropriate CROs and third party study vendors
- Clinical data review of data listings and summary tables, including query generation
Requirements:
- BS/RN degree or equivalent
- Oncology study experience required
- Demonstrated ability to work independently as well as part of a multi-functional study team
- Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process
To find out more about Real please visit www.realstaffing.com