CRA Part Time – Single Sponsor, Homebased in Lithuania
Posted 12hrs ago
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Job Description
Part-time Clinical Research Associate monitoring clinical trial sites for Syneos Health, a biopharmaceutical solutions organization. Ensuring GCP compliance, data integrity, and site performance across study lifecycles.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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

















