Senior Clinical Research Associate

🔥 1 hour ago

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provides overall support to study sites and clinical project teams engaged in clinical research studies. • Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • Manages site start up procedures including feasibility and recruitment of potential investigators. • Verifies the process of obtaining informed consent has been adequately performed and documented. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.

🎯 Requirements

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline. • Minimum of 2 years of on-site monitoring experience; 1 year oncology experience preferred. • High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). • Customer service demeanour; demonstrate flexibility and teamwork. • Ability to focus on detail for extended periods of time, high attention to accuracy. • Fluency in English communication, verbally and in writing. • Working knowledge of the drug development process. • Travelling required (60-70%).

🏖️ Benefits

• Precision Medicine Group offers competitive salary and benefits. • Health insurance and retirement plans. • Paid time off and flexible work arrangements.

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