Description
Responsibilities:- Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
- Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise
- Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
- Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects
- Monitors the sites and provides technical assistance, as necessary
- Establishes, as appropriate, internal/cross-functional/customer relationships
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related scientific field
- Requires 6-7 years of clinical research experience
- Previous experience with Global oncology clinical trials is strongly preferred
- Strong Knowledge of FDA regulatory requirements and ICH/GCP guidelines
- Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out
- Computer proficiency (MS Word, Excel, Powerpoint)
-There will be 15-30 % travel during occasional peak periods
To find out more about Real please visit www.realstaffing.com