CRA II – Sponsor-dedicated

🔥 6 hours ago

🇸🇮 Slovenia – 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 • Evaluate site and site staff performance and provide recommendations regarding site-specific actions • Escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing and administration checks • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through confirmation letters, follow-up letters, trip reports and communication logs • Support subject/patient recruitment, retention and awareness strategies • Track observations, ongoing status and action items to resolution • Manage site-level activities, communications, project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure site team training and compliance • Attend investigator, sponsor and global clinical monitoring meetings and training sessions • Support audit readiness and audit follow-up actions • Support sites throughout the real world late phase study lifecycle • Perform chart abstraction and data collection • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities • Suggest potential sites based on local treatment patterns, patient advocacy and HCP associations

🎯 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 relevant regulations and company SOPs/processes • Ability to perform clinical monitoring and site management activities on-site or remotely

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Opportunity to collaborate with colleagues across the world

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