CRA I

Job description

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. - Responsible for all aspects of site management as prescribed in the project plans. - General On-Site Monitoring Responsibilities. - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. - 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. - Monitor data for missing or implausible data. - Ensure the resources of the Sponsor and...