Senior CRA I - Co BU, South Korea

About the role

Syneos Health is hiring a CRA II / Senior CRA I for its Co BU covering South Korea, based in Seoul with a hybrid arrangement. The role covers site qualification, initiation, interim monitoring, site management and close-out, and may be titled Sr. Site Management Associate I for Real World Late Phase (RWLP) studies. It involves managing site-level activities, supporting recruitment and retention, and acting as liaison with project site personnel.

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 medical records, verify CRF data accuracy and completeness, resolve queries and check 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 ensure document archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site communications
• Prepare for and attend investigator meetings and sponsor meetings, support audit readiness and train or mentor junior CRAs
• For RWLP: site support throughout the study lifecycle, chart abstraction, data collection, country-level informed consent forms, and collaboration with the RWLP Regulatory team
• Build relationships with sponsors, medical science liaisons and local country staff, suggest potential sites and propose process improvements

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, and basic critical thinking
• Ability to travel regularly up to 75%

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP and ICH guidelines