| Research Compliance Manager -- Long Island, New York |
Author: Cynthia Hahn
Date: 01-18-10 17:13
The Office of Research Compliance at The Feinstein Institute for Medical Research/North Shore LIJ Health System is hiring a research compliance manager to join our existing audit team. The ideal candidate will have experience implementing research involving human subjects, 2-3 years experience in oversight of FDA regulated products and devices, and experience in monitoring multicenter clinical trials.
The mission of the Office of Research Compliance of the Feinstein Institute for Medical Research is to provide comprehensive regulatory guidance to the research community at the North Shore-LIJ Health System to ensure the responsible conduct of research. This includes the development of a Research Compliance Program that includes distribution of written policies, procedures and standards of conduct that promote adherence to applicable federal and New York State laws and institutional policies.
Functions of the Manager, Research Compliance
• Development and distribution of written standards of conduct, as well as written policies compliant with applicable regulations;
• Development and implementation of regular, effective education and training for all personnel engaged in research;
• Review of allegations of research noncompliance, including issues related to the protection of human subjects and research billing concerns;
• Conduct on-going audits for Good Clinical Practice (GCP) to monitor compliance and assist in the reduction of identified problem areas; and development of a system to respond to allegation or audit findings of improper/illegal activities and the enforcement of appropriate disciplinary action against employees who have violated internal research compliance polices, applicable state law, regulation or federal health care programs requirements;
• Develop and monitor benchmarks for quality improvement relating to the conduct of research;
• Provision of regulatory support for investigator-initiated studies, including monitoring the conduct of multicenter clinical trials at local and national sites;
• Conduct focused reviews of financial grants management activities;
• Conduct focused reviews of HIPAA compliance related to research;
• Process financial COI in Research disclosures in compliance with federal regulations and institutional policies.
Certified IRB Professionals and Certified Clinical Research Coordinators are encouraged to apply. Please note this position does require some domestic travel. Salary is commensurate with experience. Interested individuals should send a CV and cover letter to:
Cynthia L. Hahn Administrator Research Compliance
North Shore-LIJ Health System
The Feinstein Institute for Medical Research
350 Community Drive, 4th Floor
Manhasset, New York 11030
chahn@nshs.edu
In addition all applicants will need to complete the North Shore-LIJ on line application at https://nshs.taleo.net/careersection/2/jobsearch.ftl search for job # FEI0000FC
|
|
| Topics |
Author |
Date |
  |
Research Compliance Manager -- Long Island, New York |
|
Cynthia Hahn |
01-18-10 17:13 |
|
