CRA Part Time – Single Sponsor, Homebased in Lithuania

• 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 compliance
• Evaluate site and site staff performance and provide site-specific recommendations and 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 of site documents and medical records
• Verify clinical data entered in case report forms is accurate and complete
• Resolve queries remotely and on site and guide site staff toward closure within agreed timelines
• Use hardware and software for clinical study data review and capture and verify electronic data capture compliance
• Perform investigational product inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and release/return reviews as applicable
• Review Investigator Site Files and reconcile them with Trial Master Files
• Ensure proper archiving of essential documents
• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and required 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, budgets, and timelines
• Liaise with study site personnel and Central Monitoring Associates
• Train assigned sites and project-specific site team members
• Prepare for and attend investigator and sponsor meetings, global project meetings, and clinical training
• Support audit readiness, audit preparation, and follow-up actions
• Support sites throughout the study lifecycle from identification through close-out
• Collaborate with sponsor affiliates, medical science liaisons, and local country staff
• Train junior staff when requested
• Identify and communicate out-of-scope activities to the Lead CRA/Project Manager
• Suggest potential sites based on local treatment patterns, patient advocacy, and HCP associations

• 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
• Working knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes
• Must maintain compliance with applicable requirements and complete assigned training
• Knowledge of local requirements for real world late phase study designs
• Ability to perform chart abstraction activities and data collection
• Ability to identify and communicate out-of-scope activities
• Ability to suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and HCP associations

• 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, equity and belonging-focused workplace culture