Senior Clinical Research Associate I

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP, and protocol compliance
• Evaluate site and site staff performance and recommend site-specific actions
• Communicate and escalate serious issues and develop action plans
• Verify informed consent processes and documentation
• Assess subject safety, clinical data integrity, protocol deviations, violations, and pharmacovigilance issues
• Conduct source document review and verify clinical data accuracy and completeness
• Resolve queries remotely and on site within agreed timelines
• Verify compliance with electronic data capture requirements
• Manage investigational product inventory, reconciliation, storage, security, dispensing, and administration as applicable
• Review and reconcile Investigator Site Files 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, site status, and action items to resolution
• Manage site-level activities and communications to meet project objectives, deliverables, and timelines
• Act as liaison with study site personnel and ensure assigned teams are trained and compliant
• Attend investigator, sponsor, clinical monitoring, project staff, and training meetings
• Support audit readiness and audit follow-up actions
• For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites

• 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

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations, when appropriate, under the Americans with Disabilities Act