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 for quality and integrity
- Perform monitoring tasks efficiently and manage travel expenses
- Prepare accurate and timely trip reports
- Interact with internal work groups and act as contact for suppliers
- Manage registry management and feasibility work
- Participate in Quality Control Visits and track Serious Adverse Events
- Independently perform CRF review and query generation
- Assist with training and development of new employees
- Coordinate clinical projects and act as local client contact
Qualifications:
- University or college degree in a related field (e.g., nursing licensure)
- Basic knowledge of Regulatory Guidelines and clinical trial process
- Fluent in local office language and English
- Six 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
- Ability to maintain confidentiality and demonstrate attention to detail
- Understanding of medical and clinical research terminology
- Experience using a clinical trial management system (CTMS)