Clinical Research Associate – FSP

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

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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

• Develop strong site relationships and ensure continuity throughout all trial phases • Perform clinical study site management and monitoring in compliance with ICH/GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plans, and associated documents • Develop an in-depth understanding of study protocols and related procedures • Coordinate and manage tasks with sponsor roles to achieve site readiness • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight to ensure complete, accurate, and unbiased site data and protection of subjects' rights, safety, and well-being • Conduct validation, initiation, monitoring, and closeout visits • Prepare clear, comprehensive, and accurate visit and non-visit contact reports • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and closeout • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, and compliance problems • Maintain information and documentation in clinical trial management systems, electronic trial master files, and other systems • Contribute to CRA team knowledge as a process subject matter expert, buddy, or mentor • Support or lead audits and inspection activities • Perform co-monitoring visits where appropriate • Complete required training, timesheets, expense reports, and CV updates • Maintain compliance with Parexel/client processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Fluent in local languages and English, verbally and in writing • Excellent communication skills, including understanding and presenting technical information effectively • Good understanding and working knowledge of clinical research and phases of clinical trials • Knowledge of current GCP/ICH and country clinical research laws and guidelines • Understanding of global, country/regional clinical research guidelines • Hands-on knowledge of Good Documentation Practices • Proven site management skills, including site performance and patient recruitment • Demonstrated high level of monitoring skill with independent professional judgment • Good IT skills, including MS Office and clinical IT applications on computer, tablet, and mobile devices • Ability to understand and analyze data/metrics and act appropriately • Ability to manage complex issues in a solution-oriented manner • Root cause analysis and preventive/corrective action implementation • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to set priorities and handle multiple tasks in a changing environment • Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships • Customer focus and high quality/compliance mindset • Positive and growth mindset; self-driven and able to work independently • Professional demeanor and communication consistent with organizational policies and practices • Ability to travel domestically and internationally • Current driver's license required • Minimum 2 years of direct site monitoring experience in bio/pharma/CRO • Bachelor's degree preferred with a strong emphasis in science and/or biology

🏖️ Benefits

• Equal opportunity employment consideration regardless of legally protected status • Opportunity to contribute to therapies benefiting patients • Remote work arrangement