QARC Auditor II University of Michigan

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

This position will serve as a QA Research Compliance Specialist Senior (aka QARC Auditor II) in the Oncology Clinical Trial Support Unit (O-CTSU) providing regulatory oversight through the Quality Assurance Review Core audit program and support for external audits (ex.FDA) to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). The internal auditing program is an integral part of the Rogel Cancer Center's clinical research compliance oversight, quality assurance and process improvement activities to help ensure research subject safety, high quality data acquisition and compliance with Federal and State regulations and institutional policies. We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.

• Manages/Conducts Rogel Cancer Center Quality Assurance Review Core (QARC) audits
  • Scheduling approximately 8-10 audits a month with the appropriate research study teams at O-CTSU, Dept. CRA managed studies within UM School of Medicine and other UM Schools.
  • Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and UM/O-CTSU policies and SPGs.
  • Conduct pharmacy and regulatory reviews for the selected protocol.
  • May conduct audit of selected subject(s) source documentation including review of the MiChart, research files, labs etc.
  • Document audit findings and outcomes in appropriate repositories. Analyze audit findings to appropriately assign major or minor violations, rating the audit and drafting a QARC Audit Report for review and approval by QA Medical Director and Manager.
• Confirms CAPA actions are appropriate and completed
  • Train investigators and study staff in documentation of clinical trial activity, protocol compliance and regulatory requirements.
  • Provide support for the maintenance of the QARC SPG/Workaids pertinent to clinical trial auditing and the audit database.
  • Identify needed changes, required training through the extrapolation of the audit findings.
  • Provide guidance and mentoring to junior staff through co-auditing during initial training of new hires and act as a subject area expert to O-CTSU staff and Dept. CRAs.
  • May perform special audits upon request (Office for Humans Research Studies (OHRS) file reviews, IRB Rogel Cancer Center Associate Director, Clinical Research, or DSMC.) or may perform special projects at the request of the QA Associate Director or Data & Safety Monitoring Committee.
• Provides coordination and support for FDA and other external agency audits
  • Coordinates FDA/agency correspondence, schedules, facilities, opening/exit meetings, interviews, source documentation, resources.
  • Collaborate with Office of Research, MIAP, IRB and sponsor with daily audit updates.
  • Collaborates in development of CAPA responses.
• Maintains current knowledge of FDA, ICH, GCP, HIPAA regulations. Assist QA Manager in troubleshooting a variety of issues, compliance documentation tools, performance metrics, staff training, reviews both CTMS for data equity, collaborates with DSMC/PRC and CTSU-IT on process changes, system enhances, etc.

• Bachelor's degree in an appropriate field required.
• At least 5 years direct clinical research experience (primarily research with therapeutic intent).
• This position requires excellent written and oral communication skills with exceptional attention to detail and understanding of compliance issues with regard to human subject research
• Must be self-motivated and must possess a strong working knowledge of Code of Federal Regulations and Good Clinical Practices (GCPs), and other regulations governing clinical research.
• The ideal candidate must possess good interpersonal skills, foster teamwork and customer service orientation and have strong organizational and technology skills with the ability to multitask and prioritize.
• ACRP or SoCRA certification is required.

• Master's Degree
• 1-2 years oncology research experience.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal opportunity/affirmative action employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.