- 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.
- 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