Description
We are seeking a Clinical Research Associate to take on site monitoring and site management responsibilities for clinical studies. You will ensure the implementation of project plans, monitor study sites, and liaise with vendors.
Responsibilities:
- Conduct routine monitoring and closeout of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and other stakeholders
- Ensure study staff have received proper materials and instructions
- Verify informed consent procedures and protocol requirements
- Review data for missing or implausible entries
- Monitor data quality and ensure audit readiness
- Travel to sites and prepare trip reports
- Interact with internal work groups and external suppliers
- Manage investigator site budgets and track Serious Adverse Events
- Perform CRF review and query generation
- Assist with training and mentoring new employees
Qualifications:
- University or college degree in a related field (e.g., nursing, life sciences)
- Basic knowledge of Regulatory Guidelines and clinical trial processes
- Fluent in local office language and English
- 6 months experience in a related role (e.g., site management, study coordinator)
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field (e.g., medical, clinical, pharmaceutical)
- On-site monitoring experience
- Understanding of medical and clinical research terminology
- Experience using a clinical trial management system (CTMS)