Senior CRA I/II

• 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 provide site-specific recommendations
• Communicate and escalate serious issues and develop action plans
• Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity
• Assess site processes and conduct source document review and clinical data verification
• Resolve queries remotely and on site within agreed timelines
• Use hardware and software for clinical study data review and capture
• Verify electronic data capture compliance
• Manage investigational product inventory, reconciliation, storage, dispensing and administration compliance
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document monitoring activities and maintain tracking systems
• Support subject/patient recruitment, retention and awareness strategies
• Manage site-level activities and communication to meet project objectives, deliverables and timelines
• Liaise with study site personnel and ensure assigned site teams are trained and compliant
• Attend Investigator Meetings, sponsor meetings, clinical monitoring meetings and training sessions
• Support audit readiness and audit follow-up actions
• Provide supervision, training and mentorship to junior CRAs
• For RWLP, support sites throughout the study lifecycle, perform chart abstraction and data collection, develop informed consent forms, support regulatory activities, site strategy, RFPs, budgeting, CRF design and edit check development

• 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
• Moderate level of critical thinking 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