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. Job Qualifications Educational Background 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. Core Competencies 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. #J-18808-Ljbffr