Lead Auditor, Audit and QC+
3 weeks ago
Job Title:
Lead Auditor, Audit and Quality Control
Type:
Direct Hire
Experience
A minimum of two (2) years of experience auditing patient charts
A minimum of five (5) years of experience in clinical research and/or in oncology data management
Experience with NCTN clinical trial operations, data management, audit, and quality assurance is preferred.
Education
Bachelor's degree from an accredited college or university or relevant professional experience is required.
Certified Clinical Research Professional (CCRP) certification is strongly preferred.
Responsibilities
Coordination of the audit process for sites, including audit site and date selection
Ensures audits are conducted according to the current CTMB Guidelines and relevant FDA policies and work practices.
Participation in teleconferences, webinars, visitation of EA sites nationwide, preparation of reports, electronic and hard copy updating, and maintenance of site files.
Team selection and task assignments for audits.
Preparation of audit materials.
Assist in the recruitment of volunteer auditors (MDs and CRAs)
Provides training for volunteer CRA auditors, volunteer MD auditors, and other supportive staff as instructed.
Conducts audits in a timely fashion.
Follow through and tracking of any additional requested data/documents from sites.
Writes all audit report documents as required per CTMB guidelines.
Review audit findings for compliance per GCP, OHRP, and FDA regulations.
Works with internal staff and sites to ensure a smooth audit process.
Perform targeted source data verification in Medidata RAVE, review select source documentation remotely for compliance with protocol guidelines, issue/resolve queries where indicated.
Coordinate the internal/external meetings and revise SOPs and work practices as instructed.
Maintain all audit source docs circulation/routing of reports.
Active role in the creation of educational material for sites. Includes documents designed to help sites maintain audit readiness.
Provides training to sites at semi-annual meetings and targeted webinars as instructed.
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