Description
The Senior CRA is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Fortrea, Sponsor, and Regulatory Guidelines.
The Senior CRA 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 performing other duties as assigned
- Ensuring study staff have received proper materials and instructions to safely enter patients into the study
- Verifying informed consent procedures and protocol requirements are adhered to
- Reviewing data for missing or implausible entries
- Managing travel expenses efficiently
- Preparing accurate and timely trip reports
- Serving as lead monitor for a protocol or project
- Participating in protocol development and clinical trial report writing
- Interacting with internal work groups to evaluate needs, resources, and timelines
The Senior CRA will also be responsible for:
- Registry management
- Feasibility work
- Quality Control visits
- Recruitment of investigators
- Budget negotiations
- Serious Adverse Event reporting
- CRF review and query generation
- Training and mentoring new employees
Requirements include:
- University or college degree in life sciences or related field
- Certification in a related allied health profession or nursing certification
- Thorough knowledge of regulatory requirements
- Understanding of the drug development process
- Fluent in local office language and English
- High competence level of Clinical Monitoring experience
- Advanced study site management skills
- Ability to work with minimal supervision
- Good planning and organisation skills
- Valid Driver's License
Travel requirements: 60-80% overnight.