Clinical Research Associate – Single Sponsor

🔥 5 minutes ago

🇦🇹 Austria – 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, communicate serious issues and develop action plans • Verify informed consent, subject confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review and medical record review • Verify clinical data in case report forms and drive query resolution • Support clinical study data review, capture and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration checks • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities and track observations and action items to resolution • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities, communications, project objectives, deliverables and timelines • Liaise with study site personnel and ensure site team training and compliance • Attend investigator, sponsor, clinical monitoring and training meetings • Support audit readiness, audit preparation and follow-up actions • Maintain knowledge of ICH/GCP, regulations and company SOPs; complete assigned 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 • Previous monitoring experience in Austria • Good computer skills and ability to embrace new technologies • Fluency in German and English • Excellent communication, presentation and interpersonal skills • Ability to manage required travel for monitoring visits in Austria

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture supporting authenticity and inclusion • Diversity, equity and belonging initiatives