Description
The Senior CRA I is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Fortrea and Sponsor Standard Operating Procedures, and Regulatory Guidelines.
Responsibilities:
- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and pre-study and initiation visits.
- Manage site management as prescribed in project plans.
- Ensure study staff have 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 entries.
- Perform monitoring tasks efficiently, managing travel expenses according to Fortrea's travel policy.
- Prepare accurate and timely trip reports.
- Manage small projects under a Project Manager/Director's direction.
- Serve as lead monitor for a protocol or project.
- Participate in protocol development and clinical trial report writing.
- Interact with internal work groups to evaluate needs, resources, and timelines.
- Coordinate clinical projects as a Local Project Coordinator.
Qualifications:
- University or college degree in life sciences or a related field, or certification in a related allied health profession.
- Three years of clinical monitoring experience.
- Thorough knowledge of regulatory requirements and the drug development process.
- Fluent in local office language and English.
- Advanced site monitoring, study site management, and registry administration skills.
- Ability to work with minimal supervision and train junior staff.
Preferred Qualifications:
- Additional experience in a related field.
- Local project coordination or project management experience.
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight.