Clinical Research Associate II - Latvia (Sponsor-Dedicated)

About the role

Syneos Health is hiring a CRA II for a sponsor-dedicated position covering Latvia, working remotely. The role covers site qualification, initiation, interim monitoring, site management and close-out, and includes site support throughout the study lifecycle from site identification to close-out.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and CRFs, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and release/return
• Review the Investigator Site File, reconcile it with the Trial Master File and document activities
• Support recruitment and retention, enter tracking data, and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For Real World Late Phase studies: chart abstraction, data collection and knowledge of local study design requirements
• Collaborate with Sponsor affiliates, medical science liaisons and local country staff; may train junior staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage travel of up to 75% regularly

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Working knowledge of ICH/GCP guidelines, regulations and company SOPs