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