Clinical Trial Manager I (CRA I)

About the role

Syneos Health is hiring a Clinical Trial Manager I (CRA I) to oversee clinical trial sites. For Real World Late Phase studies, the role uses the title Site Management Associate I. The position involves site qualification, initiation, monitoring, close-out and site management, with up to 75% travel.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP and GPP 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, verify CRF 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
• Review the Investigator Site File, reconcile it with the Trial Master File and document activities
• Support recruitment, retention and awareness, enter tracking data and manage site-level activities within budget and timeline
• Act as liaison with site personnel, train sites and attend investigator and sponsor meetings
• Prepare sites for audits and follow-up actions

Required profile

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

Required skills

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