Quality Control Monitor/Auditor - Clinical Research (Remote)

The American College of Radiology is a professional association serving over 42,000 members nationwide. Consistent with the ACR's mission to advance the practice of radiology and improve the health outcomes of the populations we serve, the ACR's Center for Research and Innovation (CRI) has been a world leader in radiology clinical research for over 50 years. Over this period, the CRI has conducted clinical research trials and other research projects that have transformed the practice of radiology, informed the development of clinical practice standards, led to new device approvals, and changed healthcare policy. In addition, the CRI is the core radiology resource for NCI multicenter clinical trials involving diagnostic and therapeutic radiology. Through active research committees in neuroradiology, cardiology, oncology, and pediatrics, the CRI has developed and delivered a diverse range of research studies in partnerships with academia and commercial sponsors. Research studies range from prospective clinical trials to retrospective reader studies, novel imaging methods and software, validation of biomarkers, radiomic feature analysis, and AI algorithm development and validation.

Based on these strategic objectives, ACR is seeking a Monitor/Auditor to provide support to the ACR study initiatives across the College.

As a member of the ACR team you will:

• Perform clinical quality assurance monitoring reviews, and audit visits in accordance with contracted scope of work and regulatory requirements. Reviews/visits may be conducted remotely or on-site at enrolling institution;
• Perform monitoring and auditing activities, including: review of clinical trial eligibility, treatment, drug accountability, and AE reporting documents for compliance with protocol and completeness and consistency with the data reported on the case report forms, and drug accountability records. This may include regulatory document reviews;
• Schedule and facilitate monitoring reviews and audits;
• Prepare review materials, manage, prepare, and file all required reporting documents, including corrective and preventative action plans;
• Serve as an educational resource for institutions to prepare them for a successful monitoring and/or audit visit;
• Collaborates closely with the NRG Oncology quality assurance team and the Statistics & Data Management Center to develop and customize monitoring forms in the database and to ensure that key federal/state/local regulatory objectives are met and that ethical obligations are kept.

Qualified candidates will possess the following:

• 3+ years of monitoring/auditing clinical trials experience required. Experience in independent on-site monitoring/auditing preferred;
• Ability to travel nationwide up to 50%;

• Experience working on NCI-sponsored trials, especially the National Clinical Trials Network, preferred;
• Knowledge of Human Subjects Research, ICH/GCP guidelines, and the CTMB guidelines;
• Bachelor's degree in a related field, nursing degree, or commensurate related experience;
• Organizational and analytical skills;
• Ability to clearly communicate ideas and solutions;
• Strong verbal and written communication skills, including presentation skills;
• Ability to work as a part of a team and individually;
• Interpersonal skills, including a strong customer support focus;
• The ability to learn new skills and applications quickly. Experience working in Electronic Data Capture Systems/Clinical Trial Management Systems.

If you would like to put your experience to great use in a professional team-oriented environment, please apply online. To learn more about ACR's rewarding employee experience, culture, and benefits, visit: https://www.acr.org/jobs

ACR is committed to a total rewards compensation philosophy that includes base salary in addition to our full suite of comprehensive benefits. ACR's goal is to pay competitively and equitably. It is typical for individuals to be hired in the entry to middle of the range for their role, and compensation decisions depend on each case's circumstances. A reasonable estimate of the annual compensation range for this position is 72-95k.

ACR offers a rewarding employee experience: innovative culture, professional growth potential, competitive compensation, and an exceptional benefits package, including a defined contribution pension plan, 403(b); generous paid time off package; insurance plans with the leading providers; flexible spending; tuition reimbursement; training opportunities; and wellness reimbursement.