CRA II or SrCRA, Multi Sponsor, Belgrade

About the role

Syneos Health is hiring a Clinical Research Associate II or Senior CRA for multi-sponsor clinical studies, based in Belgrade with a hybrid arrangement. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements.

Key responsibilities

• 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
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving
• Document activities, support recruitment and retention, and track action items
• Manage site-level activities, communicate with sites and prepare sites for audits
• Attend investigator meetings, global project meetings and clinical training, and complete required training

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Ability to manage regular travel of up to 75%
• Good communication, presentation and interpersonal skills

Required skills

• Good computer skills and willingness to adopt new technologies
• Working knowledge of ICH-GCP guidelines, regulations and company SOPs