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 site support throughout the study lifecycle, chart abstraction and data collection, and for Real World Late Phase studies, the Sr. CRA I uses the business card title of Sr. Site Management Associate I.

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, security, dispensing and administration, and ensure proper labelling, import and release/return
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with site personnel, prepare for and attend investigator and sponsor meetings, and support audit readiness
• Mentor or train junior CRAs, and possibly lead global clinical monitoring meetings
• For Real World Late Phase: site identification through close-out, chart abstraction, data collection, informed consent forms, and collaboration with the regulatory team and affiliates

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice/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%