Clinical Research Associate – Single Sponsor

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 and protocol compliance • Evaluate site and staff performance and provide recommendations and action plans • Verify informed consent processes, subject confidentiality, safety and clinical data integrity • Assess site processes according to the Clinical Monitoring/Site Management Plan • Conduct source document review and verify case report form data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical study data review and capture • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through letters, trip reports, communication logs and project documents • Support subject 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 • Liaise 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 audit follow-up actions • Complete assigned training and maintain knowledge of applicable guidelines, regulations and SOPs

🎯 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 • Previous monitoring experience in Belgium • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Ability to manage required travel for monitoring visits • Good knowledge of Dutch, French and English • Working knowledge of relevant regulations and company SOPs/processes • Experience conducting clinical monitoring activities, including site qualification, initiation, interim monitoring, site management and close-out visits

🏖️ 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