CRA Level I Remote
Employer · ThermoFisher Scientific
Other health professional
Field inspectorDaytimeFull-timeRemote
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.
Tasks
- Performs and coordinates different aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
- Manages procedures and guidelines from different sponsors and/or monitoring environments.
- Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
- Ensures audit readiness.
- Develops collaborative relationships with investigational sites.
Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job in a clinical environment.
- Valid driver's license.