Senior Clinical Research Associate I (Remote)

About the role

Syneos Health is hiring a Senior Clinical Research Associate I (CRA I) for a remote position. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, ensuring regulatory, ICH-GCP and protocol compliance. The posting also notes that for Real World Late Phase studies the title used is 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 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 complies with local regulations
• Document activities via confirmation letters, trip reports, communication logs and other project documents, and enter data into tracking systems
• Manage site-level activities, communicate with sites and project teams, and adapt quickly to changing priorities
• Act as primary liaison with study sites or work with a Central Monitoring Associate, and prepare for and attend investigator meetings, sponsor meetings and clinical training
• Support audit readiness and follow-up actions
• Additional duties: site support throughout the study lifecycle, chart abstraction and data collection, collaboration with sponsor affiliates, medical science liaisons and local country staff, and suggesting potential sites based on local knowledge

Required profile

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