CRA II, Sr CRA

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP, protocol, and company SOP/process compliance
• Evaluate site and staff performance and recommend site-specific actions
• Communicate and escalate serious issues and develop action plans
• Verify informed consent processes, subject/patient confidentiality, safety, clinical data integrity, protocol deviations, and pharmacovigilance issues
• Assess site processes and conduct source document review
• Verify clinical data in case report forms and drive query resolution
• Support clinical study data review, capture, and electronic data capture compliance
• Manage investigational product inventory, reconciliation, storage, security, dispensing, and administration as applicable
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document monitoring activities through letters, trip reports, communication logs, and project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Track observations, status, and action items to resolution
• Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
• Liaise with study site personnel and ensure site/project team training and compliance
• Attend investigator, sponsor, global monitoring, project, and clinical training meetings
• Support audit readiness, audit preparation, and follow-up actions
• For real-world late-phase studies, provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff when requested, identify out-of-scope activities, and suggest potential sites based on local knowledge

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Knowledge of local requirements for real world late phase study designs
• Must be a candidate from Barranquilla, Colombia

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Total Self culture supporting authenticity, diversity, and belonging