临床监查员CRA I

该职位来源于猎聘 Work locations: Beijing / Shanghai / Guangzhou / Chengdu / Wuhan and many other cities across the country (Homebase negotiable) Job Description : As a member of the global clinical team based at the PRA offices, the Clinical Research Associate I is responsible for executing site monitoring activities under the guidance of senior CRAs and Project Managers, working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures (SOPs). Key Responsibilities:

• Conduct site visits (SIV, interim and close-out) and Source Data Verification (SDV) in accordance with the clinical monitoring plan to ensure the integrity, accuracy and traceability of clinical data;
• Take accountability for clinical supplies and follow up on drug safety issues that have occurred at your site;
• Maintain site tracking records to ensure documentation complies with TMF requirements;
• Foster effective relationships with investigator site staff to support site and patient recruitment;
• Report issues to the study team in a timely manner and assist in implementing corrective action plans. Qualifications：
• Bachelor's degree or above, majors in medicine, nursing, biology, or related fields preferred;
• Over 1 year of CRA clinical trial experience;
• Basic knowledge of ICH-GCP and local regulations;
• Good English reading and writing skills, able to handle emails and protocols in English;
• Willing to travel, with good communication and time management skills.