Initiation Clinical Research Associate – iCRA

🔥 1 minute ago

🌐 Brazil, Colombia, +1 more countries – Remote

🇧🇷 Brazil – Remote 🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 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 activation • Build strong relationships with investigators and site staff • Prepare, review, negotiate, and execute regulatory and site documents, including CDAs, ICFs, translations, and amendments • Coordinate submissions and approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities • Develop and track activation strategies, timelines, and regulatory plans • Maintain high-quality documentation in CTMS, eTMF, and TMF systems, ensuring First Time Quality (FTQ) • 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 sites remain audit- and inspection-ready throughout the study lifecycle • Maintain compliance with ICH-GCP guidelines, local regulations, sponsor requirements, and Parexel SOPs • Collaborate cross-functionally to achieve project milestones and deliverables while proactively communicating progress, risks, and issues

🎯 Requirements

• Strong clinical research and study start-up experience • Excellent problem-solving, communication, presentation, and stakeholder management skills • Ability to work independently, prioritize multiple tasks, and make decisions in ambiguous situations • Strong knowledge of CTMS, eTMF, TMF, and Microsoft Office tools • Experience working in global, matrix, and multicultural environments • High attention to detail, quality focus, and commitment to achieving project timelines • Excellent English skills (oral and written) • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or another health-related field (or equivalent experience) is preferred