Responsibilities:

• Perform qualification, initiation, monitoring, and closeout visits;
• Establish an open line of communication with site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Evaluate the quality and integrity of site practices - escalating quality issues as appropriate;
• Manage site progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory; and
• Completion of follow-up activities including visit reports and follow-up letters.

Requirements:

• Clinical Research Associate Experience (minimum 2 year);
• Approximately 20% non-local, nationwide travel is required;
• Must have a minimum of a bachelor's degree in a health or science related field;
• Proficient knowledge of Microsoft® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.

Song Zhao Hui EA License No. 02C3423 Personnel Registration No. R1761205

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