| Job Description | 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%
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| | Company | | VaxInnate Corporation | Job Code | | State or Province | | New Jersey | | |
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