Clinical Project Specialist - ??-?????? - Hengrui USA : Job Details

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.