Senior CRAI - Real World Late Phase

About the role

Syneos Health is hiring a Senior CRAI (Clinical Research Associate I) for Real World Late Phase (RWLP) studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes site support throughout the study lifecycle. For RWLP, the business card title is Sr. Site Management Associate I.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Verify informed consent and protect subject confidentiality; assess factors affecting safety and data integrity such as protocol deviations and pharmacovigilance issues
• Review source documents and medical records, verify CRF data accuracy and completeness, resolve queries and check electronic data capture compliance
• Check 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 guide sites toward audit readiness
• Mentor junior CRAs, train and sign off visits, and possibly lead clinical monitoring or project meetings
• RWLP-specific duties: site support from identification to close-out, chart abstraction and data collection, country-level informed consent forms, and bid defence meetings

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%