Description
We are seeking a Senior CRA I to oversee site monitoring and management for clinical studies. As a Senior CRA I, you will be responsible for ensuring the implementation of project plans, acting as a leader for projects of limited scope, and assuming line management responsibilities as assigned.
Responsibilities:
- Conduct site monitoring and management according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines
- Ensure the protection of study patients by verifying informed consent procedures and protocol requirements
- Monitor data for missing or implausible data and ensure the integrity of data submitted on Case Report Forms
- Manage small projects under the direction of a Project Manager/Director
- Serve as lead monitor for a protocol or project and assist in establishing monitoring plans
- Review progress of projects and initiate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Track and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation and resolution
- Assist with training and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Requirements:
- University or college degree in life science 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 in English
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision and good planning and organization skills
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field
- Local project coordination and/or project management experience