Clinical Research Auditor
Mays Cancer Center, UT Health San Antonio
Bachelorís degree and at least two (2) years of related experience in quality assurance, regulatory or healthcare areas.
This position will have primary responsibility for management of the Clinical Trials Office at the Mays Cancer Center. The Cancer Center CTO is a shared resource in the NCI-designated cancer center, and includes such functions as clinical investigations, regulatory affairs, contracts and budgets as well as fiscal oversight of all cancer-related clinical trials.
Bachelorís degree and at least two (2) years of related experience in quality assurance, regulatory or healthcare areas. Excellent Communication and writing skills, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with management, department clinical research and other team members.
Primarily monitors for all MPN-RC clinical research studies. Reviews data for accuracy, issues queries, audits drug and device accountability and regulatory documents, composes monitoring letters and conducts exit meetings with site staff and PI. Tracks and closes queries and assists with other reports on a timely basis. Collaborates with MPN-RC central office, as well as the CTO and the Quality Assurance Division to ensure that all sites and locations have all required regulatory documents prior to study initiation for MPN-RC trials. Assures all clinical site trial documentation is maintained in compliance with all applicable guidelines and corresponding procedures documents.
Participates in appropriate clinical trial committees including the Data Safety Monitoring Committee. Participates in MPN-RC related regulatory committees as deemed necessary. Provides training as needed, on identified monitoring trends to both faculty and staff. Notifies the MPN-RC central office, Dr. Mesa, and Quality Assurance Director of any unreported out of cycle issues findings
DM will be required to spend time at central office at Mount Sinai in order to become oriented to the work flow and personnel. Monitor data in the REDCap system and reach out to sites to follow up on missing data and track tissue samples in conjunction with the NYBC (New York Blood Center). Conduct site visits and may have a role in safety reporting. Ensures monitoring schedule for clinical trial data is maintained as specified per the individual protocol. Performs other duties as required.
Please apply here: uthscsajobs.com/postings/12261
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We are an equal opportunity/affirmative action employer which includes protected veterans and individuals with disabilities.