Clinical Research Associate II

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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

• Act as the primary site contact and site manager throughout all phases of a clinical research study • Take overall responsibility for allocated sites • Develop strong site relationships and ensure continuity throughout all trial phases • Perform clinical study site management and monitoring activities in compliance with ICH/GCP, SOPs, local laws, regulations, protocol, and monitoring plans • Gain 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 activities • Ensure site data are complete, accurate, and unbiased and protect subjects’ rights, safety, and well-being • Conduct validation, initiation, monitoring, and closeout visits; complete 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, deviations, regulatory documentation, audits/inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, or compliance issues • Manage information and documentation in CTMS, eTMF, and other systems • Contribute to CRA team knowledge as a process subject matter expert, buddy/mentor, and best-practice contributor • 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 (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, 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 • Ability to understand and analyze data/metrics • Ability to manage complex issues and perform root cause analysis with preventive and corrective action • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to work effectively in a matrix multicultural environment • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week • Current driver’s license required • Minimum 2 years of direct site monitoring experience in biotech/pharma/CRO • Bachelor’s degree with a strong emphasis in science and/or biology

🏖️ Benefits

• Full-time employment • Remote work arrangement • Equal opportunity employment

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