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Clinical Research Associate
2 weeks ago
**Job Description:**
We are seeking an experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing routine site visits, managing assigned sites, and ensuring site compliance.
Responsibilities:
- Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
- Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
- Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
- Identify and escalate potential risks and identify retraining opportunities for site personnel
- Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-actively follow each individual CAPA until timely resolution
- Prepare documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
- Negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
- Administer site payments in accordance with relevant project instructions