Clinical Research Associate II – FSP

🔥 16 hours 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

• Act as the primary site contact and site manager throughout all phases of clinical research studies • Develop strong site relationships and ensure continuity throughout trial phases • Perform clinical study site management and monitoring activities in compliance with ICH/GCP, SOPs, laws, regulations, protocol, and monitoring plans • Gain an in-depth understanding of study protocols and related procedures • Coordinate tasks with sponsor roles to achieve Site Ready • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight activities • Ensure site data are complete, accurate, and unbiased • Protect subjects' rights, safety, and well-being • Conduct validation, initiation, monitoring, and closeout visits • Prepare accurate visit and non-visit contact reports • Collect, review, and monitor regulatory documentation • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, audits, inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, and compliance issues • Maintain information and documentation in clinical trial management and electronic trial master file systems • Contribute to CRA team knowledge as a subject matter expert, buddy, or mentor • Support or lead audits and inspection activities • Perform co-monitoring visits • 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, phases of clinical trials, 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 skills in site management, including management of site performance and patient recruitment • Demonstrated high level of monitoring skill with independent professional judgement • 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 preventative/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 simultaneously • Ability to work effectively in a matrix multicultural environment • High quality and compliance mindset • 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 employer • Remote work arrangement (United States)

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