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Position Summary:
We have an exciting opportunity to join our team as a Quality Assurance Specialist. The Quality Assurance Specialist is responsible for monitoring and auditing the conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, the NYU IRB approved protocol and federal regulations and guidelines. Candidate will understand and practice within the scope of Federal Regulations in regards to clinical research, understand Good Clinical Practice, be CITI trained and will understand and follow the policies and procedures of the Cancer Center Clinical Trials office.
Job Responsibilities:
Prepare, plan and conduct routine monitoring visits for cancer-related, investigator-initiated and NCI-sponsored clinical trials.
Write and issue monitoring reports in accordance with standard company formats and timelines, ensuring clear communication of findings to the relevant project team members. Reviews responses to findings for appropriateness and completeness; maintain records of audits and report audit findings and corrective actions.
Support multi-site investigator-initiated trials where NYU Perlmutter Cancer Center is the coordinating center, including site activation, staff training, central patient registration, site communication and data extraction.
Monitor multi institutional sites where NYU Perlmutter Cancer Center is the coordinating center; communicate findings to sites as well as PCC Data and Safety Monitoring Committee.
Prepare, plan, and conduct internal audits of cancer center research trials.
Assist with the preparation of external inspections and audits.
Serves as a resource for PI's and Staff related to preparation for internal and external audits.
Perform other duties as assigned.
Minimum Qualifications:
To qualify you must have a Bachelor's degree in a science related field. Minimum of 2 years clinical research related experience. Strong auditing experience including the ability to write strategic audit plans. Knowledge of clinical trials audits and site visits by study monitors. Computer literacy including word processing, spreadsheet and database management skills. Excellent analytical, interpersonal, writing and verbal communication skills. Demonstrated ability to function independently. Comprehensive knowledge of Good Clinical Practice (GCP).
Preferred Qualifications:
Comprehensive knowledge of general IRB guidelines preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.
NYU Grossman School of Medicine 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, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information.
NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $67,771.14 - $81,885.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
To view the Pay Transparency Notice, please click here
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