临床监查员CRA

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: 1. 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; 2. Take accountability for clinical supplies and follow up on drug safety issues that have occurred at your site; 3.

Maintain site tracking records to ensure documentation complies with TMF requirements; 4. Foster effective relationships with investigator site staff to support site and patient recruitment; 5. Report issues to the study team in a timely manner and assist in implementing corrective action plans.

Qualifications： 1. Bachelor's degree or above, majors in medicine, nursing, biology, or related fields preferred; 2. Over 1 year of CRA clinical trial experience; 3. Basic knowledge of ICH-GCP and local regulations; 4.

Good English reading and writing skills, able to handle emails and protocols in English; 5. Willing to travel, with good communication and time management skills.