Job Summary
A healthcare company has a current position open for a Telecommute Clinical Operations Leader.
Core Responsibilities of this position include:
- Serving as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study
- Planning, conduct, and oversight of assigned Clinical Research Associate/Clinical Monitoring Associate (CRA/CMA) operational study team
- Providing metrics to the project team to demonstrate current and planned status of the study
Applicants must meet the following qualifications:
- Moderate travel may be required, 25% to 50% on a regular basis
- BA/BS degree in the science/health care field or nursing degree, or equivalent combined education and experience
- Moderate independent field monitoring experience
- Extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines
- Advanced understanding and application of applicable therapeutic standards
- Ability to apply problem solving techniques to resolve complex issues at investigator sites and within study
