Research Associate, ICRA

🔥 0 minutes ago

🌐 Brazil, Argentina, +1 more countries – Remote

🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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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

• Manage site start-up activities from feasibility and qualification through site activation • Build working relationships with investigators and site staff as the primary contact for assigned sites • Prepare, review, negotiate, and execute regulatory and site documents, including confidentiality disclosure agreements, informed consent forms, translations, and amendments • Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities • Develop and track site activation strategies, timelines, and regulatory plans • Maintain accurate, high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems • Identify, resolve, or escalate site issues and risks related to activation, recruitment, compliance, training, and data quality • Support sites with study system access, training requirements, and readiness activities • Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle • Maintain compliance with Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures • Collaborate across functions to achieve project milestones and deliverables, communicating progress, risks, and issues

🎯 Requirements

• Strong clinical research and study start-up experience • Strong knowledge of clinical trial management systems, electronic trial master file systems, trial master file processes, and Microsoft Office tools • Knowledge of International Council for Harmonization Good Clinical Practice guidelines, local regulatory requirements, sponsor requirements, and clinical trial start-up processes • Excellent oral and written English skills • Strong communication, organization, presentation, stakeholder management, and problem-solving skills • Ability to work independently, prioritize multiple tasks, and make sound decisions in ambiguous situations • Experience working in global, matrix, and multicultural environments • High attention to detail and strong quality focus • Commitment to achieving project timelines • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or another health-related field, or equivalent experience, is preferred

🏖️ Benefits

• Home-based work with flexibility • Dedicated line manager support • Strongly connected team environment • Opportunities to deepen expertise across global study start-up and regulatory operations • Flexible work culture • Growth opportunities