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Job Details

Clinical Research Auditor - Remote Flexibility

Company name
Memorial Sloan Kettering Cancer Center

Location
New York City, NY, United States

Employment Type
Full-Time

Industry
Clinical Research, Pharmaceutical, Research, Healthcare

Posted on
Sep 21, 2021

Valid Through
Jan 04, 2022

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Profile

Company Overview
At Memorial Sloan Kettering (MSK), we\u2019re 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\u2019re driving excellence and improving outcomes.  We\u2019re treating cancer, one patient at a time. Join us and make a difference every day.
 
MSK will require all new hires, volunteers, and vendors who come onsite to provide proof of COVID-19 vaccination. This is based on the COVID-19 vaccines\u2019 high level of protection and our shared responsibility in protecting our patients.
Job Description
The Clinical Research (CR) Auditor actively participates in and supports the daily operations of MSK\u2019s centralized Clinical Research Audit Program. You will work collaboratively with different teams to conduct many types of audits within Clinical Research. This role is mostly remote, but requires some onsite reporting in Manhattan between 2-10 days per year. 
You are:

Able to set priorities among several tasks and meet established goals on multiple large-scale development projects
Strategic in communication, decision-making, and analyzing situations to make recommendations and convey timely information
Excited to tackle new challenges and determine areas of improvement
Knowledgeable in GMP standards, FDA/EMA requirements, Quality Standards and Systems

You will:

Execute audits with a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP)
Work with QA Leadership to provide feedback in audits to ensure effective change control that improves overall quality
Collaborate with Principal Investigators (PIs) and Research Teams to address audit findings and developing corrective action/preventive action (CAPA) plans
Serve as the liaison and subject matter specialist between external auditors/inspectors and MSK teams during external audits and inspections

You need:

A bachelor\u2019s degree with 5 years of clinical research experience
Human Subjects Protection Certification, GCP Certification preferred
Regulatory understanding of HIPAA and human research protection regulations

Closing
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.  
 
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
 

Company info

Memorial Sloan Kettering Cancer Center
Website : http://www.mskcc.org

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