职位名称：（资深）临床检察员（Sr.）CRA 职位描述/要求：Act as the main line of communication between the Sponsor and the Investigator and investigational site. • Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. • Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines. • Ensure that the rights and wellbeing of human subjects are protected. • Ensure the trial data are accurate, complete, and verifiable from source documents. • Verifies that the investigator is enrolling only eligible subjects. • Performs verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff. • Issues and ensures timely resolution of all data queries. • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. • Communicates deviations from the protocol, SOPs, and/or gcP, to the investigator, and project management team and takes appropriate action to prevent recurrence. • Delivers quality written reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans. • Ensure that the trial is conducted and documented properly from study start-up through close-out. • Participates in site audits, as requested. • May conduct site and study feasibility assessments. • May be involved in the development of monitoring guideline and tools. • Provides input into study documentation and monitoring worksheets. • Other duties as assigned by Clinical Trial Manager/Project Manager and per project-specific requirements.
要求： • At least 3 years CRA working experience in multinational pharmaceutical, Medical Device company or CRO. • Have Medical Device or IVD clinical trials experience. CDx experience is preferred. • Familiar with clinical trial Quality Management System. • Good English skills, willing to learn, hard working. • Candidate should be major in clinical medicine or pharmacy; Pathology would be a plus. • 20% domestic travel.
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