CRA II, Sr CRA – FSP BA, FSO

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits, on-site or remotely
• Evaluate site and site staff performance and provide recommendations and action plans
• Verify informed consent processes, subject/patient confidentiality, safety, clinical data integrity, protocol deviations, and pharmacovigilance issues
• Conduct source document review and medical record review
• Verify clinical data entered in case report forms and drive query resolution to closure
• Support clinical study data review, capture, and electronic data capture compliance
• Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, import, and return when required
• 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, site status, and action items to resolution
• Manage assigned site-level activities and communications against project objectives, deliverables, budgets, and timelines
• Act as primary liaison with study site personnel and ensure site team training and compliance
• Attend investigator, sponsor, global clinical monitoring, and clinical training meetings
• Support audit readiness, audit preparation, and follow-up actions
• For Real World Late Phase, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local staff, train junior staff when requested, 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
• Total Self culture supporting authenticity and inclusion
• Diversity, belonging, and inclusive workplace culture