• Full Time
  • any

Website Lexitas

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.

Responsibilities:

  • 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.

 

Requirements:

  • 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.
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