Description
We are seeking a Senior CRA I to oversee site monitoring and management for clinical studies. You will be responsible for ensuring compliance with Fortrea and sponsor Standard Operating Procedures, as well as regulatory guidelines.
Key Responsibilities:
- Monitor and manage clinical study sites, including routine monitoring and closeout activities
- Ensure study staff receive proper materials and instructions for safe patient entry into the study
- Verify informed consent procedures and protocol requirements are followed
- Review data for accuracy and completeness, and ensure resources are used efficiently
- Travel to sites, prepare trip reports, and manage small projects as assigned
- Develop and present at Investigator Meetings, and participate in protocol development and clinical trial reporting
- Interact with internal teams, vendors, and investigators to facilitate study execution
Requirements:
- University or college degree in life sciences or related field, or certification in a related allied health profession
- 3+ 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 independently and as part of a team
Preferred Qualifications:
- Additional experience in a related field (medical, clinical, pharmaceutical, etc.)
- Local project coordination or project management experience
Physical Demands/Work Environment:
- 60-80% overnight travel required