Description
Duties:- Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
- Receives general instructions; plans and prepares studies.
- Travels to field sites to monitor studies.
- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- Monitors the sites and provides technical assistance, as necessary.
- Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
- Assists with the coordination of training and certification of study site personnel.
- With guidance, ensures accurate and complete study management/data collection and transfer into the data management system.
- Ensures site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
- Not an exhaustive list of duties
Experience Required:
- 3-5 years of previous CRA work
- IVD or medical device
- field monitoring
- Instrument data familiarity
- Electronic Data Capture systems
- Virology is preferred
To find out more about Real please visit www.realstaffing.com