Clinical Research Associate 2

Job Overview:

Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned.

Summary of Responsibilities:

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.

• General On-Site Monitoring Responsibilities.

• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

• Ensure audit re...