CRA

작업 내용

Your key responsibilities：

1. Performs site qualification,site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.

2. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

3. Conduct below activities followed Clinical Monitoring Plan Assesses site processes.

1）Conducts Source Document Review of appropriate site source. documents and medical records.

2）Verifies required clinical data entered in the case report form (CRF) is accurate and complete.

3）Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

4）Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

5）Verifies site compliance with electronic data capture requirements.

4. Perform investigational product (IP) inventory, reconciliation and reviews storage and security.

5. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

6. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.

Requirements:

1. Minimum of 2 years prior clinical research or monitoring experience.

2. Excellent oral and written communication skills in English, including proficient presentation skills required.

3. Excellent communication, collaboration, and problem-solving skills.

4. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.