CRA II – Sponsor-dedicated

🔥 43 minutes ago

🇱🇻 Latvia – 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 activities and close-out visits, on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend 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 subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site and guide site staff toward closure • Verify electronic data capture compliance • Perform investigational product inventory, reconciliation and storage/security reviews as needed • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities through required project documentation and tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities, communications, deliverables and timelines • Liaise with study site personnel and ensure assigned sites and project-specific staff 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, provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff as requested, identify out-of-scope activities, and suggest potential sites using 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

🏖️ 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 essential job functions

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