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Position Summary: We have an exciting opportunity to join our team as an Associate QA Specialist.
The Associate QA Specialist is responsible for monitoring and auditing the conduct of research protocols. The incumbent will assure 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. The incumbent 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.
Perform other duties as assigned.
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, participate and/or host external inspections and audits for assigned trials.
Participate in internal audits of cancer center research trials, including submitting all findings to the internal audit coordinator within the appropriate timelines.
Monitor and maintain records of monitoring findings and corrective actions.
Follow up as appropriate to obtain study team response. Reviews responses to monitoring findings for appropriateness and completeness.
Writes and issues monitoring visit reports in accordance with standard company formats and timelines, ensuring clear communication of monitoring findings to the relevant project team members.
Prepare, plan, and conduct internal monitoring visits of investigator-initiated cancer center research trials.
Minimum Qualifications: To qualify you must have a Bachelors degree in a science related field. Minimum of 1 year in clinical research-related experience Excellent analytical, interpersonal, writing and verbal communication skills Knowledge of clinical trials audits and site visits by study monitors Demonstrated ability to function independently Computer literacy including word processing, spreadsheet and database management skills 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: 67269173
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.