Other information:
BASIC KNOWLEDGE:
� Bachelor�s degree in Applied or Life Sciences or related area including courses in research methodologies and microcomputer systems. In lieu of a bachelor�s degree an additional 2-3 years of experience may be substituted.
� Knowledge of theory and techniques of research methodology
� Must possess the following skills:
o Detail-oriented and excellent organizational skills
o Strong-self-starter
o Interpersonal skills
o Team-oriented
o Excellent oral and written communication skills
o Proficient in Microsoft office and in various database applications
EXPERIENCE:
6 months - 1 year in direct clinical trial administration experience or relevant administrative experience preferred but not required.
The Regulatory Assistant should develop general understanding of compliance requirements with federal state and/or local programmatic regulations within three months of employment.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:
This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.
INDEPENDENT ACTION:
This position requires a quick-thinker who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies including but not limited to study sponsors local and federal agencies. This person should also be able to work with outside monitors and work independently. He/she should be able answer inquiries related to regulatory issues and if not known communicate with the correct person to determine the answer.
SUPERVISORY RESPONSIBILITY:
None
