Description
The American College of Radiology is a professional association serving over 42,000 members across the country. 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 which have transformed the practice of radiology, informed the development of clinical practice standards, led to new device approvals, and changed healthcare policy.
The CRI serves as the core radiology resource for NCI multicenter clinical trials involving diagnostic or therapeutic radiology. And, 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 imaging software, validation of biomarkers, radiomic feature analysis, and AI algorithm development and validation.
Based on these strategic objectives, ACR is seeking a Quality Assurance Specialist to provide support to ACR QA initiatives across the College.
Roles and Responsibilities
- Perform Good Clinical Practice (GCP) internal audits (study, process, software systems, etc.). Including production of audit plans, reports, collecting responses, and follow-up.
- Participate in hosting inspections (e.g., FDA and external audits by sponsor). Including communication with agency/sponsor, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.
- Participate in vendor qualification audits as assigned. Including production of audit plans, reports, collection of responses, and follow-up;
- Assist in developing, recommending, and monitoring corrective and preventive actions.
- Support the development (writing) and periodic review of standard operating procedures and work instructions for different functional areas.
- Assist project teams with developing and maintaining eTMFs for each project.
- Conduct Good Clinical Practices (GCP), 21 CFR Part 11, and other internal trainings as required.
- Participate in continuously improving and maintaining our quality management system and assist with compliance activities.
- Serve as a source of advice and guidance on all quality/GCP and other regulations matters for internal staff.
Qualifications and Experience
- 2+ years of Good Clinical Practices (GCP) related experience required; auditing experience is preferred.
- Bachelor’s degree required.
- Certification as a Quality Auditor or related certificate is a plus.
- Thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including 21 CFR Part 11, 50, 312, 812, 820.
- Experience with Electronic Documentation Management System (EDMS) and Electronic Master File system (eTMF).
- Exceptional technical writing, review, and analytical abilities.
- Excellent communication and interpersonal skills. Must be assertive, but diplomatic; always striving for win-win situations.
- Strong MS Office skills necessary.
