Clinical Research Auditor
Job Posting Number: 15150
New York, NY
October 11, 2017
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 27th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Reports directly to Senior CR Auditor, the Clinical Research(CR) Auditor actively participates in and supports the daily operations of MSK’s centralized clinical research audit program. The incumbent is a participating member of the CR Audit Team.
- Conduct all types of audits (protocol compliance, CR financial, CR database systems, etc), as dictated by QA Leadership.
- Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH (International Center for Harmonization) guidance on Good Clinical Practice (GCP).
- Perform required number of audits each quarter, supporting team members with audits as needed.
- Work with QA Leadership to provide feedback, deficiencies and common trends identified in Audits to ensure timely and effective change control to improve overall quality.
- Collaborate with Principal Investigators and Research Teams on audit findings, corrective action and preventive plans.
- Bachelor’s degree with at least 5 years of clinical research experience.
- 2 years of management experience.
- Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
- Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
- Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
- Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff and patients at MSK as well as appropriate external contacts.
- Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
- Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
- Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
- Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSKCC is essential.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
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