Responsible for performing clinical monitoring tasks and duties in accordance with regulations. Manages, coordinates, and supports clinical monitoring activities.
- Monitor clinical trials from pharmaceutical companies and biotech companies, in-house.
- Manage, coordinate, and support clinical monitoring activities, including investigator and site selection.
- Collect regulatory documentation and ensure accuracy.
- Collect drug and supply management.
- Perform data collection.
- Conduct visits and preside over prequalification, qualification, initiation, monitoring, and termination.
- Receive inbound and outbound calls.
- Review recruitment plan and enrollment updates.
- Resolve issues from previous visits.
- Address protocol questions.
- Assess drug supply status.
- Request outstanding documents and ensure they are filled out.
- Perform data entry.
- Review site payment status.
- Create and distribute study document.
- Complete in-house site specific files.
- Monitor relevant tracking system.
- Train team members.
- Perform regular reviews of data according to data review/monitoring guidelines.
- Develop and write trial protocols.
- Monitor the trial throughout its duration, which involves visiting the study centers on a regular basis.
- Set up study centers and ensure all documentation is present.
- Close down centers upon completion of trial.