Initiation Clinical Research Associate I/II

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Own site startup: Build strong relationships with investigators and site staff, manage qualification visits, and guide sites through regulatory approvals (IRB/IEC, MoH/RA) • Drive regulatory excellence: Prepare and negotiate ICFs, manage protocol amendments, and ensure all documentation meets regulatory requirements • Ensure readiness: Coordinate training, system access, and compliance checks so sites launch on time and audit-ready • Manage the details: Maintain CTMS and eTMF records with first-time quality; resolve site issues proactively • Think strategically: Forecast timelines, identify risks early, and develop solutions independently

🎯 Requirements

• Substantial startup experience in clinical research • Some startup experience or knowledge of in clinical research • Degree in biological science, pharmacy, nursing, or health-related field (or equivalent experience) • Knowledge of ICH-GCP guidelines and clinical trial methodology • Proficient in Serbian language • Second languages preferable (French, Poland, Danish, Swedish, Finnish, Hungarian, Spanish) • Ability to make sound decisions in ambiguous situations and work with urgency

🏖️ Benefits

• Health insurance • Retirement plans