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.
The Senior CRA I will implement project plans, lead projects of limited scope, and assume line management responsibilities as assigned.
Key responsibilities include:
- Conducting site monitoring, including routine monitoring and closeout of clinical sites
- Maintaining study files and conducting pre-study and initiation visits
- Liaising with vendors and ensuring study patients' protection and data integrity
- Monitoring data for missing or implausible entries and ensuring audit readiness
- Preparing accurate and timely trip reports and managing small projects
- Serving as lead monitor for a protocol or project and assisting in establishing monitoring plans
- Reviewing progress of projects and initiating actions to achieve target objectives
- Organizing and making presentations at Investigator Meetings
- Participating in protocol development and writing clinical trial reports
- Interacting with internal work groups to evaluate needs, resources, and timelines
- Acting as contact for clinical trial supplies and other suppliers
- Managing registry management and undertaking feasibility work
- Conducting Quality Control visits and tracking Serious Adverse Event reporting
- Independently performing CRF review and query generation
- Assisting with training and mentoring new employees
The Senior CRA I should possess:
- A university or college degree in life sciences or a related field, or certification in a related allied health profession
- At least 3 years of clinical research experience in the pharmaceutical or CRO industries
- 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 good planning and organization skills
- Good computer skills and advanced verbal and written communication skills
- Valid Driver's License
Travel requirements: 60-80% overnight.