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Senior Clinical Research Associate - Onco - TW

Remote · Japan Full-time

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. 

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. 

Make an Impact as a Senior Clinical Research Associate at Worldwide

As a Senior Clinical Research Associate, you will play a critical role in ensuring the quality, integrity, and success of clinical research studies. Your work will directly support the collection of accurate data, the protection of study participants, and the delivery of high-quality research outcomes.

In this role, you will partner closely with investigative sites, study teams, and sponsors to guide studies from site qualification through close-out. You'll bring leadership, expertise, and a strong understanding of clinical research regulations to help drive study performance and ensure compliance with global and local requirements.

You'll also have the opportunity to contribute beyond study monitoring by mentoring colleagues, supporting study planning activities, participating in investigator meetings and bid defenses, and helping advance monitoring and site management practices.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Taiwan. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month.

To best support our sites, we're seeking candidates who are based in Taiwan. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.

What You'll Do

  • Lead site qualification, initiation, monitoring, and close-out activities to ensure studies are conducted in accordance with protocols, GCP, SOPs, and applicable regulations.
  • Build strong relationships with investigative sites and provide ongoing support to drive study quality, compliance, and timely data submission.
  • Review source documentation, study data, safety reporting, and informed consent processes to protect participant safety and data integrity.
  • Coordinate and maintain essential regulatory and ethics documentation, ensuring inspection readiness and complete trial records.
  • Collaborate with project teams to track study milestones, resolve operational challenges, and support successful study delivery.
  • Mentor and guide less experienced CRAs and site personnel, sharing expertise and supporting effective study execution.
  • Contribute to clinical monitoring plans, study tools, training programs, investigator meetings, and bid defense activities.
  • Evaluate investigational product accountability, site compliance, and operational processes while documenting findings through clear and accurate reports.

What You'll Bring

  • MD, Pharmacy degree (MSPH, PharmD, PhD, or equivalent), plus a minimum of 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, physical, health, pharmacy, or related science field plus 5 years of CRA experience; OR a two-year college curriculum/equivalent training (nursing or life sciences preferred) plus 7 years of CRA experience.
  • Extensive experience in clinical research monitoring and site management across the clinical trial lifecycle.
  • Thorough knowledge of ICH-GCP, FDA and/or EU regulations, local regulatory requirements, and clinical research processes.
  • Strong understanding of at least two to three therapeutic areas with the ability to function as a Lead CRA.
  • Experience using EDC systems, IxRS platforms, and Microsoft Office applications.
  • Excellent communication, organizational, time management, problem-solving, and interpersonal skills.
  • Proficiency in English and fluency in the local language(s) of the countries under responsibility, both written and spoken.
  • Experience in full-service monitoring PREFERRED

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.

MD, Pharmacy degree (MSPH, PharmD, PhD) plus 3+ years CRA experience, or 4-year degree in medical/biological/health science plus 5 years CRA experience, or 2-year college plus 7 years CRA experience; ICH-GCP, FDA/EU regulations; EDC, IxRS, Microsoft Office; English and local language proficiency.

Key Responsibilities

  • monitoring clinical trials
  • managing site activities
  • mentoring colleagues

Skills & Tools

EDC, IxRS, Microsoft Office

Job Details

  • Category: Research and Development (R&D)
  • Seniority: Senior Level
  • Commitment: Full Time
  • Workplace: Remote — Taiwan
  • Languages: English, Chinese

About Worldwide Clinical Trials

A global contract research organization improving lives through high-quality clinical research. — Industry: Research and Development

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