CRA II – Sponsor-dedicated

🕒 2 days ago

🇭🇷 Croatia – 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 and provide recommendations regarding site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes and protect subject/patient confidentiality • Assess patient safety, clinical data integrity, protocol deviations, violations, and pharmacovigilance issues • Conduct source document review and verify clinical data entered in case report forms • Resolve queries remotely and on site and guide site staff toward closure • Manage investigational product inventory, reconciliation, storage, dispensing, administration, and related documentation • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs, and 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, and timelines • Act as liaison with study site personnel and ensure assigned sites and project team members are trained and compliant • Attend investigator, sponsor, global monitoring, and clinical training meetings • Support audit readiness and preparation for audits 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 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 ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes • Ability to perform clinical monitoring and site management activities in compliance with protocols and regulations

🏖️ 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, to assist employees or applicants with disabilities

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