Senior Clinical Research Associate – Sponsor Dedicated – Cardiology

2 days ago

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits • Uses judgment and experience to evaluate overall performance of site and site staff • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan • Supports subject/patient recruitment, retention and awareness strategies. • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements

🎯 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 • Must demonstrate good computer skills and be able to embrace new technologies • Excellent communication, presentation and interpersonal skills • Moderate level of critical thinking skills expected • Ability to manage required travel of up to 75% on a regular basis.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities