CRA bij de sponsor - Nederland

Syneos Health is seeking an experienced CRA to join the team in The Netherlands. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conduct Source Document Review of appropriate site source documents and medical records
• Verify required clinical data entered in the case report form (CRF) is accurate and complete
• Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Previous monitoring experience in The Netherlands
• Excellent communication, presentation, and interpersonal skills
• Fluency in Dutch and English
• Ability to manage required travel for monitoring visits throughout the country