System One

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.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.