JOB SUMMARY

This position provides administrative and coordination support for the conduct of clinical research in neuroendocrinology. The candidate will provide support for the initiation and conduct of new clinical trials and ongoing support for a Phase IV clinical trial. This position is the entry level position on the Michigan Medicine CRC Career Ladder.

REQUIRED QUALIFICATIONS*

High school diploma or GED is necessary.

DESIRED QUALIFICATIONS*

Undergraduate degree in a science or math field. Some experience in neuroendocrinology research is desirable.

Knowledge of all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwor

CHARACTERISTIC DUTIES AND RESPONSIBILITIES:

Knowledge of all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

RESPONSIBILITIES*

Provide support for the initiation and conduct of human subjects research. This includes: liaison with other University collaborators, edit study-related documents, oversee regulation including IRB amendments and approvals and HIPAA compliance. Provide study startup support oversee the implementation of clinical trials including contacting eligible subjects, obtaining their consent, oversee and document study visits in the Michigan Clinical Research Unit, enter participant data into the relevant databases, and liaise with clinical trial monitors.