Provides oversight to research projects involving human subjects. Oversight will entail centralized clinical monitoring activities and conducting clinical research quality assurance reviews. Serves as a specialist on Federal regulations pertaining to research involving human subjects and on the International Conference on Harmonization Good Clinical Practices.

Major Duties / Critical Tasks:

• Monitors research projects involving human subjects by conducting reviews of research documentation, including Regulatory Binder, Correspondence files, Case Report Forms, Adverse Event Reports and IRB Documentation and by monitoring the informed consent process. Provides oral or written feedback to appropriate research staff.
• Serves as resource for all Investigators, Nurses, and Study Coordinators with regard to the Federal regulations (especially NIH and FDA regulations) and the International Conference on Harmonization good Clinical Practices.
• Assists with the development and implementation of a risk assessment process for research projects involving human subjects.
• Assists in solving problems or resolving complex clinical situations as they arise.
• Assists with the investigation of alleged non-compliance and the documentation as necessary.
• Assists in the development and revisions of policies and procedures related to research projects involving human subjects.
• Assists with education and training programs designed to promote adherence to policies and regulations for staff involved in human subject research.
• Works on special projects.
• Attends professional meetings and maintains certifications as appropriate.
• Adheres to internal controls established for Department.
• Performs related duties as required.

Required Education / Experience:

Associates degree in related field and three years of clinical trials experience.

Equipment:

Standard hospital, clinical and office equipment.

Working Environment:

Standard hospital, clinical and office environment.

Other: