(Senior) Unblinded Clinical Research Associate

 Posted an hour ago
  
 Taiwan
  
2-5 years experience
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AI Summary

The role involves performing independent unblinded monitoring behind a blinding firewall, including pharmacy oversight and Investigational Product (IP) accountability. You will conduct site visits, ensure protocol compliance, and collaborate with pharmacy teams to maintain trial integrity.
FSP-(Senior) Unblinded Clinical Research Associate- Remote in Taiwan

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


As an Unblinded CRA II at ICON, you will perform independent unblinded monitoring behind an established blinding firewall, oversight of Investigational Product (IP) and pharmacy processes across sites—including international travel to Singapore—and contribute to the advancement of innovative treatments and therapies while maintaining strict trial integrity.

What You Will Do:

You will contribute to unblinded clinical trial monitoring activities, taking responsibility for pharmacy oversight, IP accountability, and maintaining blinding integrity while working collaboratively with sponsor and site pharmacy teams.

Key responsibilities include:

  • Conducting unblinded site qualification, initiation, routine monitoring, and close-out visits in local and international sites (specifically Singapore), focusing on pharmacy processes and IP management.

  • Ensuring protocol compliance, IP accountability, temperature log verifications, and patient safety throughout the trial process without compromising trial blinding.

  • Collaborating with site pharmacists and pharmacy staff to facilitate smooth study conduct, unblinded dispensing, and proper IP disposal/return.

  • Performing unblinded data review, pharmacy documentation checks, and resolution of pharmacy queries to maintain high-quality clinical data in restricted access spaces (e.g., uMVRs).

  • Contributing to the preparation and review of unblinded study documentation, including pharmacy manuals, unblinded monitoring plans, and IP destruction logs.

Your Profile:

You will bring relevant clinical trial monitoring experience with a focus on unblinded/pharmacy oversight, along with the following qualifications and skills.

Required qualifications and experience:

  • Bachelor's degree in Pharmacy, Life Sciences, or a healthcare-related field (Registered Pharmacist license preferred).

  • Minimum of 2 years of experience as a Clinical Research Associate, including independent site monitoring visits.

  • In-depth knowledge of clinical trial processes, unblinded monitoring procedures, local regulations (including HSA Singapore guidelines), and ICH-GCP guidelines.

  • Strong organizational, integrity-driven, and communication skills, with meticulous attention to detail regarding IP management.

  • Ability to work independently and maintain strict blinding firewalls in a fast-paced environment.

  • Willingness and flexibility to travel as required, including regular regional travel to Singapore (approximately 50% in Taiwan or to Singapore).

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    Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


    Rewards & Benefits

    ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


    Benefits may include:

    • Competitive base salary and performance related incentives
    • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
    • Retirement and pension plans
    • Life assurance and disability coverage
    • Employee assistance programmes and wellbeing resources
    • Learning and development opportunities through structured training and career pathways

    Benefits may vary depending on role and location.


    Visit our careers site to read more about the benefits ICON offers.


    Inclusion and Accessibility

    ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


    If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

    Are you a current ICON Employee? Please click here to apply

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