Clinical Research Associate II (Latvia) - Remote, Sponsor-Dedicated

About the role

Syneos Health is hiring a remote, sponsor-dedicated Clinical Research Associate II (CRA II) for Latvia. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and ensures regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the CRA II uses the business card title of Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, evaluating site performance and escalating serious issues
• 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, labelling and release, and reconcile the Investigator Site File with the Trial Master File
• Document activities, support recruitment and retention, and prepare sites for audits
• Attend investigator and sponsor meetings, clinical training and global project meetings
• Support site support throughout the study lifecycle, chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff
• For Real World Late Phase: use the Site Management Associate II title, suggest potential sites and train junior staff when requested

Required profile

• Bachelor's degree or RN in a related field, or equivalent 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