Clinical Trials Quality Assurance Auditor
Location: Amherst, NY
Description: Clinical Trials Quality Assurance Auditor for a large, newly funded NIH sponsored cancer prevention research network. The role of the Quality Assurance Auditor is to confirm institutional and investigator compliance with network guidelines and clinical research protocols according to applicable regulations and Good Clinical Practice (GCP), interfacing with Principal Investigators, study team members, and other research personnel in order to carry out this responsibility.
Primary Areas of Responsibility:
- Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity
- Conduct in depth reviews of IRB approved research studies for compliance with federal/state regulations, GCP, NCI, institutional, and network requirements, and best practices; ensure adherence to the institutional Data and Safety Monitoring Plan (DSMP)
- Work with study teams to formulate Corrective and Preventive Action Plans (CAPAs) based on audit findings, deviations, and events; conduct follow up audits to assess if the desired effect/change was achieved
- Use the quality assurance process as an opportunity for continuing education of study teams
- Prepare audit reports, as well as initial and follow-up communications to sites
- Create, organize and maintain tracking systems and tools to support the auditing of a network of cancer prevention studies
- Support of site personnel via email, phone or web-based
- Participate in procedure and software development/improvement
- Other duties as assigned
- Bachelor's Degree minimum, preferably in a related field
- Familiarity with medical concepts and research terminology, preferably in oncology
- Knowledge of ICH and GCP Guidelines, planning, implementation, coordination, evaluation, and reporting of clinical trials
- Prior Clinical Trials auditing experience
- Knowledge of Electronic Data Capture Systems such as Medidata RAVE
- Familiarity with documenting audit findings, communicating findings, and following up with site personnel on CAPAs, and preparing final reports
- Excellent communication skills (written and verbal) and the ability to build effective relationships with site staff and colleagues
- Strong working knowledge of MS Office Suite and willing to learn and use other commercial software packages
- Excellent organizational and interpersonal skills
- Detail-oriented, resourceful, positive and professional demeanor
- Ability to work independently, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines
On the job learning required. This is an office-based position located in our Amherst, NY office. The candidate must be willing to travel frequently and be flexible in scheduling on-site audits with 2-3 weeks notice.
Email resume/cover letter to firstname.lastname@example.org and include CPNetQA_202007 in the subject line.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.