Clinical Research Associate 临床研究助理（诊断试剂）

Responsibility:
• Oversees the progress of clinical stu******** ensuring that they arecon******** recorde******** reporte******** accordance with theprotocol, Standar******** Procedures (SOPs), Goo******** Practice (GCP)an******** applicable Regulatory requirements.
• Establishes regular lines of communication with clinical study sitesto manage ongoing project expectations an********.
• Get ethical approval, study agreement signe******** studyreporte********.
• Identifies an******** potential study sites an******** for inclusioninto investigational site pool
• Serves as the interface to phys******** laboratorians an********opinion leaders.
• Conduct on-site monitoring visits in accordance with Goo********Pract******** ICH guidelines an******** operating procedures.
• Assists in the review of clinical data an******** of study reports forregulatory submission.
Qualification********
• Bachelors or Master Degree in the Biological Sciences or Medicaldiscipline
• Minimum 2 years of clinical research experience includingdemonstrate******** in site monitoring (including pre-stu**************** routine monitoring an******** visits). IVD study experiencestrongly preferred.
• Goo******** of medical device/IVD development processes, clinicaltrial monitoring proce******** medical terminology an********/ICHguidelines
• Excellent organ******** teamwork an******** solving skills an********skills
• Familiar with statistical analysis
• Willingness to travel
• Goo******** skills.
• Fluent in local office language an******** Engl******** both writtenan********.