CRA Part Time – Single Sponsor, Homebased in Lithuania

This is a fully remote position, open to applicants in Lithuania.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits either on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, protocols, and company SOPs.

• Assess the performance of sites and site personnel, providing tailored recommendations and action plans.

• Confirm informed consent processes, maintain subject/patient confidentiality, ensure safety, uphold clinical data integrity, address protocol deviations, and manage pharmacovigilance matters.

• Review site processes and perform source document evaluations of site documents and medical records.

• Validate that clinical data recorded in case report forms is both accurate and complete.

• Resolve inquiries both remotely and on-site, guiding site personnel toward timely closure.

• Utilize hardware and software tools for clinical study data analysis and ensure compliance with electronic data capture regulations.

• Oversee investigational product inventory, including reconciliation, storage, security, dispensing, administration, labeling, importation, and return/release reviews as necessary.

• Examine Investigator Site Files and ensure their reconciliation with Trial Master Files.

• Guarantee the proper archiving of essential documents.

• Document activities through confirmation letters, follow-up correspondence, trip reports, communication logs, and other required project documentation.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, site status, and track action items to resolution.

• Manage site-level activities and communications to achieve project goals, deliverables, budgets, and timelines.

• Coordinate with study site staff and Central Monitoring Associates.

• Train designated sites and project-specific team members.

• Prepare for and participate in investigator and sponsor meetings, global project meetings, and clinical training sessions.

• Facilitate audit readiness, preparation, and necessary follow-up actions.

• Support sites throughout the study lifecycle, from identification to close-out.

• Collaborate with sponsor affiliates, medical science liaisons, and local country personnel.

• Provide training to junior staff as requested.

• Identify and report out-of-scope activities to the Lead CRA/Project Manager.

• Recommend potential sites based on local treatment trends, patient advocacy, and healthcare professional associations.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% on a regular basis.

• Working knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes.

• Must adhere to compliance with applicable requirements and complete assigned training.

• Understanding of local requirements for real-world late-phase study designs.

• Ability to conduct chart abstraction activities and collect data.

• Capacity to identify and communicate out-of-scope activities.

• Ability to suggest potential sites based on local insights regarding treatment practices, patient advocacy, and HCP associations.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Recognition from peers.

• Comprehensive total rewards program.

• A culture of total self, promoting authenticity and inclusion.

• A workplace culture focused on diversity, equity, and belonging.