CRA Part Time – Single Sponsor, Homebased in Lithuania

🔥 16 minutes ago

🇱🇹 Lithuania – Remote

⏱ Part Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

infoinfo
Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Syneos Health

Syneos Health

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

Apply Now