Clinical Research Associate

🔥 4 hours ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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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 provide recommendations on site-specific actions • Escalate serious issues to the project team and develop action plans • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety, protocol deviations or 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 • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, security, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through required letters, reports, 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 primary liaison with study site personnel or collaborate with a Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend investigator and sponsor meetings • Participate in global clinical monitoring/project staff meetings and clinical training • Support audit readiness and audit follow-up actions • Maintain knowledge of applicable guidelines, regulations and company SOPs and complete required training

🎯 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 • Previous monitoring experience • Excellent communication, presentation and interpersonal skills • Fluency in Danish and English • Preferably a good understanding of Swedish and Norwegian • Ability to manage required travel of up to 75% on a regular basis • Ability to perform cross-border monitoring in the Nordics if 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

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