Senior Clinical Research Associate

🕒 June 30

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision Medicine Group

WebsiteLinkedInAll Job Openings

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. • Acts as point of contact for study sites. • Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels. • 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, preparation of EC/IRB submissions, collection and review of regulatory documents. • Assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. • Verifies process of obtaining informed consent has been adequately performed and documented for each subject/patient. • Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits. • Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs. • Supports subject/patient recruitment, retention and awareness strategies.

🎯 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； • Global Clinical Trial experience • 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

• Health insurance • Flexible work arrangements • Professional development