Senior Clinical Research Associate

🔥 2 minutes ago

🇵🇱 Poland – Remote

💵 zł230k - zł260k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Serve as primary site contact and site manager throughout all phases of clinical research studies • Take overall responsibility for allocated sites and develop strong site relationships • Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, and monitoring plans • Gain an in-depth understanding of study protocols and related procedures • Coordinate tasks to achieve Site Ready status and provide input on site selection and validation • Perform remote and on-site monitoring and oversight • Conduct validation, initiation, monitoring, and close-out site visits • Record accurate visit and non-visit contact reports in a timely manner • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and site performance • Identify, assess, and resolve site performance, quality, and compliance problems • Escalate issues in collaboration with the Clinical Research Manager and Partner Line Manager • Manage information and documentation in the Clinical Trial Management System, electronic Trial Master File, and other systems • Contribute knowledge as a process subject matter expert, buddy, or mentor • Support or lead audit and inspection activities and perform co-monitoring visits • Complete required training, submit timesheets and expense reports, update CV, and comply with Parexel and client processes and applicable requirements

🎯 Requirements

• Proven skills in site management, including management of site performance and patient recruitment • A demonstrated high level of monitoring skill with independent professional judgement • Ability to understand and analyze data and metrics, and to act on them appropriately • Solution-oriented approach to complex issues, with root cause analysis and implementation of preventive and corrective actions • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Strong verbal and written communication skills, including ability to understand and present technical information effectively • Ability to work effectively in a matrix, multicultural environment and build culturally sensitive working relationships • Customer focus, with a quality and compliance mindset • Positive, growth mindset and self-driven approach, with ability to work independently • High sense of accountability and urgency, with ability to set priorities and handle multiple tasks simultaneously • Good IT skills, including MS Office and clinical IT applications on computer, tablet, and mobile devices • Fluent in the local language and English, both verbal and written • Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research law and guidelines • Good understanding of global and country/regional clinical research guidelines • Hands-on knowledge of Good Documentation Practices • Minimum 2 years of direct site monitoring experience in bio/pharma/CRO • Current driver's license • Ability to travel domestically and internationally approximately 65%-75% of working time, approximately 2-3 days per week • Bachelor's degree in science (Biotechnology, Pharma, Biology) preferred

🏖️ Benefits

• Premium salary • Attractive benefits • Car or car allowance • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • People who motivate and face challenges together • Innovative technology • Excellent training • Paid time off • Life insurance • Health insurance • Additional benefit offerings in accordance with the terms of applicable plans • Potential eligibility for additional incentives, bonuses, or other compensation programs

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