SCRA/CRA Sweden

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Clinical Research Associate

Summary

Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete, and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.

Responsibilities

• Performs pre-study, initiation, interim monitoring, and close-out visits according to applicable SOPs, GCP, and FDA Guidelines.
• Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data.
• Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations, and data integrity.
• Assists with the tracking and reporting of enrollment and works with the site to identify enrollment issues, barriers, and strategies.
• Responsible for maintaining or gathering site/project-specific information as directed by the sponsor and project management.
• Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation
  
  

Minimum Requirements

• B.S./B.A. in a health-related or scientific field and a minimum of 5 years of experience in clinical research, or an equivalent combination of education and experience.
• Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
• Ability to travel
  
  

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