CRA II / Site Management Associate II (Barranquilla, Colombia)

About the role

Syneos Health is hiring a CRA II or Senior CRA, also referred to as Site Management Associate II, assigned to a client's FSP (Field Support Program) in Barranquilla, Colombia. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes chart abstraction and data collection. Only candidates from Barranquilla, Colombia are considered.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and GPP compliance
• 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
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Support site recruitment and retention, enter tracking data and prepare sites for audits
• Take part in investigator meetings, global monitoring meetings and clinical training, and suggest potential sites
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection and knowledge of local study design requirements

Required profile

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

Required skills

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