Description
We are seeking a Clinical Research Associate to oversee site monitoring and management for clinical studies. As a Clinical Research Associate, you will be responsible for ensuring the implementation of project plans, monitoring study sites, and maintaining study files.
Responsibilities:
- Conduct routine monitoring and closeout of clinical sites
- Maintain study files and ensure proper documentation
- 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 accuracy and completeness
- Monitor data for missing or implausible entries
- Ensure audit readiness at the site level
- Travel to clinical sites as required
- Prepare accurate and timely trip reports
- Interact with internal work groups to evaluate needs and resources
- Act as contact for clinical trial supplies and vendors
- Manage registry management and feasibility work
- Participate in quality control visits and track serious adverse events
- Assist with training and development of new employees
- Coordinate clinical projects as a Local Project Coordinator
Requirements:
- 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
- Six months of experience in a related role (e.g., site management, study coordinator)
- Valid driver's license
- Good planning, organization, and problem-solving skills
- Good computer skills with working knowledge of Microsoft Office applications
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)