As an Inhouse CRA you play a crucial part in the smooth conduct of the Clinical research process:
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to :
- Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations.
- Assists in writing sections of the protocol summary, annual report and other study reports.
- Assists in the development and review of informed consent document to ensure all required elements are included.
- Assists with site nomination, qualification, and selection processes.
- In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.
- Coordinates activities with study specific committees, vendor services, and core labs.
- Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries.
- Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
- Reviews and processes product complaints and adverse events as soon as they are reported.
- Drafts Serious Adverse Event narratives.
Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.
- Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards. Notify appropriate study management when concerns exit.