Description
Overview:This role is responsible for all aspects of developing, implementing and closing Design Control Studies including verification and validation studies, and Clinical Studies conducted by Clinical Affairs involving instruments, software and reagents used in tissue-on-slide based in-vitro diagnostic tests.Assist with or manage pre-study coordination and determination of readiness including record keeping for the following activities:
- Study site management
- Protocol and Case Report form development
- Data entry
- Data Verification
- Training investigators and their study team
- Study supplies management
- Monitor work to ensure quality, and continuously promote Quality First Time
Requirements:
- Bachelors degree in a scientific discipline or equivalent degree
- 4-6 years of clinical monitoring experience
- Experience with medical device or diagnostic clinical trials
- Strong science background; lab experience highly preferred
- Available to travel up to 30 % during occasional peak periods
To find out more about Real please visit www.realstaffing.com