Clinical Research Associate; CRA

Job Responsibilities & Qualifications

Key Responsibilities:

• Conduct monitoring activities including investigative site feasibility assessment, site initiation, routine monitoring and site close-out, and submit corresponding reports in accordance with SOP requirements after each monitoring visit.
• Timely report project progress, encountered challenges and identified issues at investigative sites to the company; coordinate with all relevant parties to assist sites in resolving problems and formulate preventive measures.
• Provide project-related training to investigative sites, maintain regular communication with sites, and facilitate communication and liaison between the project management team and investigative sites.
• Distribute updated study protocols and other project documents to investigative sites in a timely manner to ensure sites implement the latest project requirements.
• Collect and file site-related documents into the Trial Master File (TMF) in a timely manner, and ensure all documents comply with required quality standards.
• Complete and submit all required reports and feedback as requested by the company. Undertake other ad hoc tasks assigned by the immediate supervisor.

• Master’s degree in Clinical Medicine, Pharmacy or other related disciplines.
• Familiar with GCP, ICH-GCP and relevant laws and regulations; proficient in the full workflow of clinical site monitoring.

• Strong learning ability:
  Proactively study laws, regulations, company and departmental SOPs related to clinical trials, and adjust work approaches timely in response to updates of regulations and SOPs.
• Excellent communication skills.
• Strong execution capability with solid teamwork awareness.