Hengrui USA
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.
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.