Clinical Research Associate II

7 hours ago

Taipei Taipei City, Taiwan ClinHope Consulting Co., Ltd. Full time $90,000 - $120,000 per year

Company Description

ClinHope is a dynamic and fast-growing CRO in its early stages, offering a flexible work environment, a collaborative team culture, and an exciting, thriving atmosphere. We believe in innovation, teamwork, and supporting our employees to grow alongside the company. At ClinHope, you'll be joining a vibrant and energetic workplace where new ideas are encouraged, and every team member plays a crucial role in our success.

Role Description

The Clinical Research Associate II (CRA2) is responsible for monitoring clinical trials to ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. The CRA plays a crucial role in site management, data integrity, and ensuring that clinical trials meet ethical and scientific standards. This position involves frequent interaction with investigators, site personnel, and internal study teams.

Key Responsibilities

  • Conduct site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols and regulatory guidelines.
  • Ensure the accuracy, completeness, and integrity of clinical data collected at study sites.
  • Verify that informed consent procedures are properly followed at all sites.
  • Identify, document, and follow up on site issues, deviations, and non-compliance, implementing corrective and preventive actions as needed.
  • Provide ongoing training and support to site staff regarding protocol requirements and study procedures.
  • Maintain essential documents and ensure regulatory compliance at each study site.
  • Collaborate with investigators and study teams to ensure patient safety and data reliability.
  • Prepare detailed monitoring reports and communicate findings to relevant stakeholders.
  • Work closely with cross-functional teams, including regulatory, medical writing, submission, and project management teams, to ensure trial success.

Qualifications

  • Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
  • Minimum of 1 year of experience in clinical research monitoring.
  • Strong knowledge of ICH-GCP, FDA regulations, and other applicable clinical research guidelines.
  • Excellent communication and organizational skills.
  • Ability to work independently and manage multiple clinical sites.
  • Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) systems.
  • Willingness to travel for site visits and meetings as required.
  • Having a background in ophthalmology study is an advantage.

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