Clinical Studies Specialist IV

Looking for someone with study management experience and prior site monitoring experience (CRA). Travel will be less than 25%. Leads, designs, plans, and monitors all clinical trial phases to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

Hours:

Average of 20 hours a week but may increase into next year. Hours will fluctuate each week. This person could be located out of Roswell, GA or Neenah, WI. May consider a home based resource.

Skills:

- Bachelor's degree in a relevant discipline with 2-5 years of experience
- Experience in Project management
- Experience in clinical research
- Business communication skills
- Knowledge of device/pharmaceutical regulations (510K, PMA)

Responsibilities:

- Leads clinical project teams and represents clinical affairs on multi function projects teams internally/externally
- Assist in the design of clinical protocols and trial case report forms

Oversees external consultants including contract research organizations and Clinical Research Associates. - Responsible for providing trial status updates to project teams and management.
- Responsible for clinical study budgets

Interested candidates should send a copy of their Resume including salary/rate information.