Description
Senior Clinical Research Associate- 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.
- Assumes accountability for the collection and maintenance of regulatory documentation, as applicable.
- 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)
- Manages material logistics for the studies.
- Conducts reference material testing in-house.
- Supports the organization of investigator meetings, as necessary.
- Makes sound recommendations to solve problems
- Establishes, as appropriate, internal/cross-functional/customer relationships.
- Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects.
- Assists, prepares and manages study timelines.
- Participates in Project Team Meetings.
- Keeps informed of trends and developments in clinical research.
- Analyzes alternative approaches to solve problems or devleop new perspectives on existing solutons.
Education Requirement:
B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.
Previous Experience:
Clinical Research Associate: Typically requires 2-6 years relevant clinical research experience, 4-6 years preferred.
Travel:
Clinical Research Associate: Able to accommodate 15-35% travel during occasional peak periods.
To find out more about Real please visit www.realstaffing.com