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ASSOCIATE DIRECTOR OF RESEARCH

BRONX, NY, US


The Associate Director of Research Integrity trains and manages clinical research audit staff, conducts clinical research audits and assists the Director of Research Integrity with investigation of potential research misconduct.  Must be able to quickly and accurately identify compliance issues that required an urgent institutional response; have broad clinical knowledge and the ability to understand complex clinical research protocols of all design from all therapeutic areas; accurately interpret state and federal regulations as they apply to each research project.

 

Education/skills required:

 

Bachelor's Degree in Nursing and currently registered in NY State.

7 to 10 years experience coordinating, conducting or monitoring human subjects research, including 5+ years demonstrated competence as a clinical research auditor.

3+ years experience conducting audits when research misconduct is suspected or the investigation is conducted pursuanrt to institualonal Research Misconduct Policy.

Knowledge of all state and federal regulations and guidance applicable to human subject research (including 21 CFR 50 and 56, and 45 CFR 46, 21 CFR 312, 21 CFR 814 and 21 CFR 11 of the US Code of Federal Regulations).  GCP as recommended by the FDA, and HIPAA.

 

Experience with the use of the following software:  electronic medical records systems, clinical trail management systems, MS Office/MS Word, Excel and Powerpoint.

 

Department: Research Bargaining Unit: Non Union Campus: MOSES  Employment Status: Regular Full-Time Address: 3308 Rochambeau Avenue, Bronx
Shift: Day Scheduled Hours: 8:30 AM-5 PM Req ID: 102080 

 

Montefiore is an equal employment opportunity employer. Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law. 

 

#GDMD; N/A 


Mission:
To heal, to teach, to discover and to advance the health of the communities we serve.

Vision:
To be a premier academic medical center that transforms health and enriches lives.

Values
Define our philosophy of care, they shape our actions and motivate and inspire us to pursue excellence and achieve the goals we have set forth for the future. Our values include:

  • Humanity
  • Innovation
  • Teamwork
  • Diversity
  • Equity