Description
We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for site monitoring and site management for clinical studies according to Company and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
Responsibilities:
- Conduct routine monitoring and closeout of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and perform other duties as assigned
- Ensure study staff have received proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements are adhered to
- Review source documents to ensure data integrity
- Monitor data for missing or implausible data
- Perform monitoring tasks efficiently according to SOPs and guidelines
- Ensure audit readiness at the site level
- Travel may be required, including air travel
- Prepare accurate and timely trip reports
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Manage registry management as prescribed in project plans
- Undertake feasibility work when requested
- Participate in Quality Control Visits
- Recruit potential investigators and prepare EC submissions
- Track and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation
- Assist with training and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree in a related allied health profession
- Basic knowledge of Regulatory Guidelines and clinical trial process
- Fluent in local office language and in English
- Six months experience in a related role
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field
- 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