Primary Duties:

• A member of the project management team that ensures all deadlines are met and maintains a close effectual working relationship with, Coordinators and Investigators assigned to studies;
• Coordinate and manage activities as related to the conduct of all phases of clinical trials;
• Implement and conduct study planning, execution, monitoring and completion activities;
• Assist with developing and maintaining databases for tracking of regulatory documents, work flow process and other essential trial related documents;
• Review Clinical Trial Agreements;
• Review and approve Informed Consent Forms for submission to sites IRB;
• Review protocols and assist and approves case report form design;
• Organize and prepare trial related material and presentations for Investigator meetings/presentations;
• Train Investigative sites on protocol and procedures;
• Provide centralized investigative site support, communication and coordination to assure accurate and timely completion of all contracted activities;
• Conduct monitoring visits and complete monitoring reports Set up, populate and maintain the clinical trial monitoring/management tracking systems;
• Resolve issues at Investigative sites;
• Ensure that clinical studies are performed following Company policy and in compliance with FDA requirements.
 

Background:

• B.S. Degree in Science/Health related field;
• 3-5 years prior experience in clinical study and site management;
• Experience in conducting site visits independently;
• Must be available to travel by car or air domestically for overnight trips up to 30%.
 

Resumes from recruiters will not be considered.