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Position Summary: We have an exciting opportunity to join our team as a QA Specialist-Cancer CTO.
This person 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.
Monitor multi institutional sites that the NYU Perlmutter Cancer Center is the coordinating center
Follow up as appropriate to obtain audit response. Reviews responses to audit findings for appropriateness and completeness.
Prepare, participate and or host external inspections and audits
Monitor and maintain records of audits and report audit findings and corrective actions.
Serves as a resource for PIs and Staff related to preparation for internal and external audits
Writes and issues audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
Conducts follow-up audits as appropriate or when required to verify effectiveness of corrective actions following an internal audit and or external audit
Assist in documentation, preparation, and submission as required from pre and post external inspections
Prepare, plan, and conduct internal audits of cancer center research trials
Conduct SIVs for sub-sites in which NYU Perlmutter Cancer Center is the coordinating center
Minimum Qualifications: To qualify you must have a Bachelor's Degree and 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) and general IRB guidelines preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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 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 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. To view the Pay Transparency Notice, please click here.
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Internal Number: 68115434
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.