Shift: Day
Working Hours: 8a-5p
Summary:
This individual is responsible to apply knowledge of clinical trial operations, Good Clinical Practice (GCP), and ICH guidelines to assure regulatory compliance in all clinical trials conducted at Baptist Health. Primary focus to prepare study documents for trial start up including Investigator Agreements, initial IRB submissions and electronic regulatory binder creation.
Other information:
Bachelor's degree in an appropriate area of science, nursing, research and/or hospital administration and a minimum of 3 years professional experience in research field. Degree requirement may be substituted with an equivalent combination of education, training and experience. Holds specialty certification in clinical research through an approved accrediting organization preferred. Candidate must be able to read, analyze and concisely summarize scientific protocols, regulatory documentation. Ability to manage a busy schedule with multiple demanding projects and frequently shifting priorities. Must be able to handle confidential and/or sensitive information in an appropriate and professional manner. Ability to actively participate as a team player.
This job will be authorized 80.00 hours bi-weekly.