Clinical Research Associate II
PSI CRO · Taipei
Job description
About the role
We are looking for a motivated Clinical Research Associate II to join our global clinical research team in Taipei. The role focuses on managing the clinical aspects of full‑service projects, ensuring patient safety, data quality, and regulatory compliance across a range of therapeutic areas.
Key responsibilities
- Conduct and report all types of onsite monitoring visits, including Phase II/III studies.
- Participate in study start‑up activities, such as site selection, feasibility, and regulatory document preparation.
- Perform CRF review, source document verification, and query resolution.
- Facilitate site budgets, contract negotiations, and ongoing site communication.
- Monitor trial progress at the country level and act as the primary contact for internal support services and vendors.
Required profile
- College or university degree in Life Sciences, Pharmacy, Nursing, or an equivalent combination of education and experience.
- 2‑3 years of independent on‑site monitoring experience in Taiwan.
- Experience with monitoring visits in Phase II and/or III clinical trials.
- Familiarity with therapeutic areas such as Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, or Infectious Diseases (preferred).
- Full professional proficiency in English and Chinese.
Required skills
- On‑site monitoring and source document verification.
- CRF review and query management.
- Site budget preparation and contract negotiation.
- Regulatory document support for study submissions.
What we offer
- Opportunity to work on global clinical research projects with a leading CRO.
- Collaborative, multicultural environment focused on scientific innovation.
- Professional development and career growth within a rapidly expanding organization.
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PSI CRO
Taipei
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