Site Monitor/CRA- All US Locations & Levels - FSP - (, , Remote)

Site Monitor/CRA- All US Locations & Levels - FSP - (, , Remote)

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.

Education

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Proficiency in local language preferred. English is required

Experience

• A minimum of 12 months experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)

Skills and Technical Competencies

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Demonstrated networking and relationship building skills
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes