Clinical Research Associate VaxInnate

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.

Location:	Three Cedar Brook Drive Cranbury, NJ 08512 United States