CLINICAL RESEARCH ASSOCIATE

40.000.000 - 80.000.000


This position is responsible for project management and study site management from site selection toinitiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermedor sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization GoodClinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicableregulations; The position is responsible for ensuring that all data generated by the assigned sites is of high quality,on time and within budget. 2. Responsibilities: Study site selection, initiation (SIV) and clinical monitoring; Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements; Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements; Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files; Prepare/complete study records’ archiving according to protocol and sponsor requirements; Ensure safety information is disseminated to all sites according SOP and applicable regulations; Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations; Finalize budget and obtain signed contract from site, prior to site initiation visit; Ensure Study Payment Schedule is executed and retain relevant documents/receipts; Update and maintain Study tools/systems in a timely manner. 3. Qualifications: Bachelor degree or above in Medical, Pharmacology or Biology related major; Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; At least 1-2 years of CRA experiences; Good command of written and verbal English; Good skills on Microsoft Word, Excel, PPT and Outlook, etc.; Other abilities such as Communication skills/Information-gathering skills. Knowledge and/or experience in medical practice is a plus. Welcome passion and creative ideas' friends! Look forward to receiving your CV. Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Research and Project Management Industries Pharmaceutical Manufacturing and Research Services Referrals increase your chances of interviewing at Tigermed by 2x Sign in to set job alerts for “Clinical Research Associate” roles. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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