CRA II – Sponsor-dedicated

🔥 1 hour ago

🇸🇰 Slovakia – 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 • Ensure regulatory, ICH-GCP/GPP, protocol, and company SOP compliance • Evaluate site and site staff performance and recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent, subject/patient confidentiality, safety, clinical data integrity, and protocol compliance • Conduct source document review and verify CRF data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • Review investigational product inventory, storage, security, dispensing, administration, and reconciliation • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities through letters, reports, communication logs, and project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, action items, project scope, budgets, and timelines • Act as liaison with study site personnel and ensure site/project team training and compliance • Attend investigator, sponsor, monitoring, and clinical training meetings • Support audit readiness, audit preparation, and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites

🎯 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 • Ability to perform site qualification, initiation, monitoring, management, and close-out activities • For Real World Late Phase: knowledge of local requirements for real world late phase study designs • For Real World Late Phase: chart abstraction and data collection capabilities

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate

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