Clinical Project Specialist — 恒瑞-全球精英计划 Job at Hengrui USA, Princeton, NJ

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  • Hengrui USA
  • Princeton, NJ

Job Description

Job Responsibilities:

  • Assist with planning, initiation, execution, and closure of US-based clinical trials (Phase I–III).
  • Support the development and tracking of study timelines, budgets, and operational plans.
  • Coordinate vendor activities and support vendor management (CROs, central labs, clinical trial suppliers, etc.).
  • Assist with site management activities, including site selection, start-up, monitoring, and close-out activities.
  • Ensure study activities align with FDA regulations, ICH-GCP guidelines, and company SOPs.
  • Maintain study documentation (protocols, reports, investigator brochures, etc.) and ensure version control.
  • Prepare meeting materials and support cross-functional project team meetings.
  • Track and report study progress, issues, and risks to the study team and management.
  • Support audit readiness and assist during regulatory inspections.
  • Collaborate with and provide operational support to clinical team members.

Job requirements:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
  • 2 -4 years of clinical research experience, (CRA, CTA, or project coordination experience preferred).
  • Familiarity with ICH-GCP, FDA regulations, and US clinical trial requirements.
  • Strong organizational skills with attention to detail and ability to manage multiple tasks.
  • Effective communication and collaboration skills.
  • Proficiency with clinical trial management systems (CTMS), EDC, and MS Office Suite.
  • Willingness to travel occasionally (up to 10-15%).

Preferred Qualifications

  • Experience in oncology, rare disease, or other specialized therapeutic areas.
  • Prior experience in a biotech or pharmaceutical sponsor or CRO environment.

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