Clinical Research Associate

2 weeks ago

Taiwan OPIS s.r.l. Full time $60,000 - $80,000 per year
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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