CRA II – Multi Sponsor

🔥 1 hour ago

🇺🇦 Ukraine – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

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 • Evaluate site and site staff performance, communicate or escalate serious issues, and develop action plans • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Conduct source document review and verify clinical data entered in case report forms • Resolve queries remotely and on site, guide site staff, and ensure closure within agreed timelines • Use hardware and software for clinical study data review and capture; verify electronic data capture compliance • Perform investigational product inventory, reconciliation and storage/security reviews as required • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage assigned site-level activities and communications to meet project scope, deliverables, budgets and timelines • Act as primary liaison with study site personnel or collaborate with Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, global monitoring/project meetings and clinical training • Provide site and project-level guidance for audit readiness and support audit preparation and follow-up • For Real World Late Phase, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons and local country staff, train junior staff when requested, identify out-of-scope activities, and suggest potential sites based on local knowledge

🎯 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 relevant regulations and company SOPs/processes • Ability to perform site qualification, initiation, monitoring, management and close-out activities • Ability to work with clinical data, source documents, medical records, CRFs, EDC systems, ISF and TMF • Ability to support investigational product inventory, reconciliation, storage, dispensing and administration verification • Ability to prepare and maintain required clinical trial documentation • Ability to support audit readiness and follow-up actions

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Collaboration with colleagues across the world • Remote work arrangement (Remote (Pre-Approved))

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