Clinical Research Associate

Are you a proactive and detail-oriented CRA ready to take your career to the next level?

Join a quality-focused, science-driven CRO where your work will truly make an impact.

At OPIS , we support cutting-edge clinical research across global markets — and we’re looking for talented professionals like you to help deliver high-quality clinical trials that improve patient outcomes 🔍 Your Role As a Clinical Research Associate , you’ll be a key member of our Clinical Operations team — overseeing and coordinating clinical trial activities in line with ICH-GCP, regulatory requirements, and study protocols.

You’ll work closely with both investigative sites and internal teams to ensure trial success from start to finish.

• What You’ll Be Doing 🔎 Identify and assess investigator sites; participate in feasibility assessments for new studies 🏥 Conduct site visits (selection, initiation, monitoring, close-out) in accordance with the protocol and regulatory requirements 🖥️ Perform remote monitoring as required, adhering to SOPs and timelines 📝 Support the Trial Start-up team in gathering ethical and administrative documentation 📊 Monitor site performance to ensure recruitment targets are met and motivate investigators accordingly ✅ Review informed consent procedures for accuracy and compliance 🗂️ Track study progress : regulatory submissions, CRF completion, data queries, etc.

Verify and report serious adverse events (SAEs) per SOPs and sponsor procedures 📁 Maintain study files and documentation for TMF and ensure proper archiving 📃 Document site visits, findings, follow-ups, and action plans with high-quality reporting ✅ What We’re Looking For 🎓 University degree in a scientific or life science field 🧪 2+ years of hands-on experience in clinical trial monitoring 📚 Strong knowledge of ICH-GCP and regulatory requirements 💡 Ability to independently manage trial monitoring tasks 💬 Excellent communication skills in English (written & verbal) 🧠 Organized, problem-solving mindset and proactive attitude 💻 Proficient in MS Office Suite (Word, Excel, PowerPoint) ✈️ Willingness and ability to travel as needed 🌟 Why Join OPIS? 💼 Competitive salary and bonus structure 🌱 Career development opportunities in a growing international company 🧬 Work on meaningful clinical research that impacts real lives 🌍 Collaborate with a passionate, expert team in a dynamic and flexible work environment 🧬 Who We Are Founded in 1998 in Italy and now operating globally, OPIS is a full-service Contract Research Organization (CRO) dedicated to delivering top-tier support in all phases of clinical trials.

We combine scientific rigor with cutting-edge technology to manage complex, multi-country studies — while providing specialized services across medical writing, regulatory affairs, pharmacovigilance, statistics, and beyond.

We pride ourselves on our people — experienced professionals who bring deep expertise, commitment to quality, and a shared mission of advancing science and improving patient outcomes.

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