Summary: Lexitas Clinical Research Associates (CRAs) need to have at least 2 years of field monitoring experience with some experience in ophthalmology. An ideal candidate will be one who is comfortable in a fast-paced, small company environment and works well as part of a dynamic project team. Lexitas CRAs are proactive problem solvers who focus on building and investing in relationships with investigators and site staff.
- Performs pre-study, initiation, interim monitoring and close out visits according to applicable Standard Operating Procedures (SOPs) and FDA Guidelines.
- Scientifically monitors clinical studies, which includes the review of case report forms (CRFs) to ensure adherence to the protocol and consistency and scientific validity of the data.
- Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.
- Provides technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials.
- Assists with the tracking of enrollment rates, receipt and review of completed CRFs to ensure the efficient execution of a clinical trial.
- Supports with creating and implementing project specific processes and tools.
- Responsible for maintaining project specific spreadsheets as directed by project management.
- Supports project management staff with study related issues as directed.
- Coordinates the collection and approval of regulatory documents and maintenance of study files and study documentation.
- Assists other team members with site-specific issues, acting as liaison between study staff and project staff.
- This position requires a B.S./B.A. or advanced degree in a healthcare-related or scientific field and at least 2 years of experience in clinical monitoring.
- Some experience in ophthalmology is required.