Description
Fortrea is seeking a Clinical Research Associate to monitor and manage clinical study sites according to company and sponsor standard operating procedures and regulatory guidelines.
The successful candidate will be responsible for:
- Conducting routine monitoring and closeout of clinical sites
- Maintaining study files and conducting pre-study and initiation visits
- Liaising with vendors and ensuring the implementation of project plans
- Ensuring the protection of study patients by verifying informed consent procedures and protocol requirements
- Reviewing data for missing or implausible entries
- Preparing accurate and timely trip reports
- Interacting with internal work groups to evaluate needs, resources, and timelines
- Acting as a contact for clinical trial supplies and other suppliers
- Managing investigator site budgets
- Tracking and following up on serious adverse event reporting
- Performing CRF review and query generation and resolution
- Assisting with training and development of new employees
- Coordinating designated clinical projects as a Local Project Coordinator
The ideal candidate will have:
- A B.A./B.S. degree with a strong emphasis in science and/or biology
- At least 2 years of direct site monitoring experience in a bio/pharma/CRO
- Basic knowledge of regulatory guidelines and the clinical trial process
- Fluent in local office language and in English, both written and verbal
- Experience using IVRS, EDC, TMF, and other systems
- Good planning, organization, and problem-solving skills
- Ability to work within a project team and efficiently in a matrix environment