Clinical Research Associate II – Sponsor-dedicated

🔥 6 minutes ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟠 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 site compliance • Evaluate site and staff performance and communicate or escalate serious issues • Verify informed consent, subject confidentiality, safety, clinical data integrity, and protocol compliance • Conduct source document review and verify clinical data accuracy and completeness • Resolve data queries and verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, and returns as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, reports, logs, and project documentation • Support subject recruitment, retention, and awareness strategies • Track observations, action items, site status, deliverables, budgets, and timelines • Act as liaison with study site personnel and ensure site teams are trained and compliant • Attend investigator, sponsor, project, and clinical training meetings • Support audit readiness, audit preparation, 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, 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 • Oncology experience will be a plus • 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 65-75% on a regular basis • Working knowledge of relevant regulations and company SOPs/processes • Must complete assigned training as required

🏖️ 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