Location: Alliance for Clinical Trials in Oncology Chicago Office
The Quality Assurance Manager (QAM) will assist in the implementation of initiatives in response to requests from the National Cancer Institute; assist in the implementation of new initiatives for purposes of ensuring regulatory compliance with all relevant regulations and requirements. The QA Manager will also conduct Alliance institutional audits to ensure the protection of human subjects and compliance with all relevant regulations and the Clinical Trials Monitoring Branch Guidelines.
Develops and manages quality monitoring and assurance process for trials submitted to regulatory authorities as part of an Investigational New Drug (IND) application and New Drug Application (NDA).
Ensures that timelines for reporting data are met and monitors metrics for data quality and other key performance indicators. Determine requirements for further monitoring/auditing as required. 35%
In conjunction with the Audit Program Director, develops and maintains a Food and Drug Agency (FDA) inspection readiness program for the Alliance
Develops guidelines to ensure compliance with trial master file requirements, staff training, sponsor obligations and other issues relevant to Good Clinical Practice (GCP) and federal regulations for clinical trials.
Develops policies and procedures to ensure ethical study conduct, the protection of human subjects, data integrity, data security, and the privacy and confidentiality of patient health information and personally identifiable health information.
Reviews inquiries related to regulatory issues and provides guidance to internal staff and site personnel to ensure compliance with regulatory requirements.
Serves as liaison in the event of an FDA inspection and assists with any inspection activities, as needed. 30%
Function as the Lead Staff Auditor. Writes the audit reports. Submits audit reports to the Clinical Trials Monitoring Branch (CTMB) and the audited site.
Advises clinical trial sites regarding corrective action plans for improvement of the institutional clinical trial program, including changes to the policies and procedures of the research and regulatory offices, institutional resources and responsibilities of research personnel.
Assist to develop and implement training programs for auditors and institutional personnel, including workshops, online training modules, job aids and on-the-job training of new auditors.
Assists Audit Program Director to ensure consistency of audit policy interpretation and application by all audit committee members and ad hoc auditors
Ensure compliance with the Alliance Audit Policies and Procedures, Good Clinical Practice, CTMB Guidelines, and Pharmaceutical Management Branch Guidelines. 20%
Manages collection of deviations in protocol compliance from the data base. Assists the executive officer/physician with monitoring deviations in protocol compliance. Determine deviation severity and requirements for further monitoring/auditing as required. 5%
Evaluate new protocols and protocol amendments to determine level of institutional IRB review required by Alliance as the national trial sponsor, e.g., full board vs. expedited review 5%
Keeps abreast of current regulations and guidelines affecting the conduct of clinical trials by participating in national associations for regulatory personnel. Review relevant regulations, policies and guidance documents, e.g., FDA and OHRP guidance regarding adverse event reporting. Develop related implementation plan for policy and procedure changes. 5%
Strong Problem Solving Skills
Strong Communication skills
Ability to work with minimal supervision
Education, Experience or Certifications:
Bachelorâ™s degree required
A minimum of two years of regulatory compliance experience required
Working Conditions and Physical Requirements:
A minimum 20% travel is required to conduct Alliance audits. Travel preferred to Alliance Committee and Group Meetings.
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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Internal Number: JR04118
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