Clinical Research Associate I / II - FSP (Remote)

About the role

Syneos Health is hiring a Clinical Research Associate I or II (Functional Service Provider) for a remote position. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. It may also involve real-world late-phase study support, chart abstraction and site identification.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries within agreed timelines
• Check site compliance with electronic data capture requirements
• Review investigational product inventory, storage and security, and verify dispensing and administration according to the protocol
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving complies with local regulations
• Support subject recruitment and retention, enter observations and action items into tracking systems, and prepare for audits
• Act as liaison with site personnel, attend investigator and sponsor meetings, and mentor or train junior CRAs
• For real-world late-phase studies: support the study lifecycle, abstract charts, collect data, identify sites, develop country-level informed consent forms and suggest process improvements

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills, and basic critical thinking
• Ability to travel regularly up to 75%