| Senior IRB Compliance Analyst -- Los Angeles, CA |
Author: Rebecca Flores Stella
Date: 06-13-08 18:48
A health care organization firmly based in the community, Cedars-Sinai is also an academic medical center where future generations of physicians, nurses and other caregivers are trained, and where world-class biomedical research takes place both in the laboratory and via clinical trials. This unique, multi-pronged approach to medicine translates to superior care for our patients.
In response to a growing research program, Cedars-Sinai Medical Center (CSMC) announces a new position of Senior IRB Compliance Analyst in the Office of Research Compliance. INTERESTED INDIVIDUALS should forward a resume and cover letter to Keren Dunn, Manager, Compliance and Quality Improvement, keren.dunn@cshs.org.
The Senior IRB Compliance Analyst is a professional position working under the general supervision of Manager, Research Compliance and Quality Improvement.
The incumbent will provide high-level professional support to assist the Manager in the continuous development and expansion of the IRB Compliance and Post-Approval Monitoring Program. Major responsibilities in this area include the following: auditing ongoing human research protocols on a regular basis and if necessary, conducting on-site surveillance of subject consenting process to ensure that the investigators’ practice conforms to applicable regulations, policies, ethical principles, and IRB approved protocols; auditing IRB records maintained by the Office of Research Compliance to assist in continuous performance improvement efforts; assisting the Manager in the resolution of compliance issues, as needed; drafting detailed reports outlining audit findings, recommendations, and corrective actions; and working with the Manager on a continuous performance improvement plan to monitor and improve the performance of the Office of Research Compliance.
The incumbent will work closely with the Senior IRB Education Analyst and the IRB Analyst Team Leader to accomplish effective real-time monitoring of IRB and IRB staff review and processing activities. Will also use findings from the Post-Approval Monitoring Program to identify topics for educational efforts and working with the Senior IRB Education Analyst and the IRB Analyst Team Leader to execute these. Works with the Manager to provide general guidance and education to IRB staff, IRB members, investigators and research staff on compliance-related matters.
The incumbent will also be responsible for projects assigned to support the institution’s ongoing accreditation in human subject protection principles.
Conducts special projects as assigned by the Manager, Research Compliance and Quality Improvement or the Director of Research Compliance.
MINIMUM JOB REQUIREMENTS/COMPETENCIES:
Qualifications include a Master’s degree and 2 years IRB-related experience or 4 years relevant experience in clinical trial, health care, public health, or the equivalent; or a Bachelor’s degree and 4 years IRB-related experience or 6 years relevant experience in clinical trial, health care, public health, or the equivalent. A certification of “Certified IRB Professional” is required at the earliest opportunity after employment, but no later than 2.5 years of employment.
The incumbent must have detailed knowledge of federal, State, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. This knowledge is important since the incumbent acts as liaison between the IRB and investigators to assure uniformity of application of regulations to research done at CSMC. In addition, the incumbent must possess a working knowledge of a significant body of scientific and medical concepts and terminology to assist in investigating on possible violations of human protection regulations and policies, and to evaluate actions taken by investigators in response to committee requests.
The incumbent must have detailed knowledge of federal, State, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research.
The incumbent must have excellent interpersonal, communication, and organizational skills to work effectively with IRB Analysts, Managers, Director, investigators, IRB Chairs, committee members, administrators and federal regulatory and funding agencies.
INTERESTED INDIVIDUALS should forward a resume and cover letter to Keren Dunn, Manager, Compliance and Quality Improvement, keren.dunn@cshs.org.
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Author |
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Senior IRB Compliance Analyst -- Los Angeles, CA new |
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Rebecca Flores Stella |
06-13-08 18:48 |
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