Job Title: Lead Auditor, Audit and Quality Control
Type: Direct Hire/Permanent
Schedule: Hybrid 2-3 days onsite in Philadelphia
Experience
• Must have experience in GCP auditing for clinical trials.
- 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.