| Regulatory Attorney -- Seattle, WA |
Author: Jelynne Dimitrova
Date: 05-08-08 12:47
Quorum Review, an accredited independent Institutional Review Board (IRB) and a leader in the industry for overseeing research participant safety is seeking a Regulatory Attorney to provide legal counsel to board members and staff and develop policy and guidelines for use across the business.
Primary responsibilities will include advising the IRB by:
-Provide clarity and guidance to board members and staff regarding legal or regulatory issues such as: conflict of interest, recruitment practices, state-law requirements, HIPAA requirements, and etc.
-Analyze, and make policy recommendations in the interpretation of federal laws, state laws and FDA regulations pertaining to IRB operations and functions, including 21 CFR 11, and the HIPAA Privacy Rule.
-Pre-reviewing negotiations with sites and sponsors.
-Revise and further develop action a plan required to address/correct deficiencies identified in audit results and reviews/approves final audit response letters.
-Legal review of contracts including: service agreements, confidentiality agreements, and allocation of IRB jurisdiction agreements.
The ideal candidate will have 3-5 years of proven success in the application of health law and/ or related regulatory issues and must possess a Juris Doctorate degree.
As an accredited IRB with over 100 employees, Quorum strives to provide superior processes and guidelines throughout our business. Your high standards in legal analysis, quality and accuracy of work, and leadership on regulatory matters will be valued.
Compensation is DOE with a comprehensive benefit package.
For consideration, submit letter of interest and resume to Human Resources online at www.quorumreview.com. E-mail and Fax submissions will not be considered.
Quorum Review is an Equal Opportunity and Affirmative Action Employer.
No brokers/ agents, and headhunters please. We are located in Downtown Seattle
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Date |
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Regulatory Attorney -- Seattle, WA new |
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Jelynne Dimitrova |
05-08-08 12:47 |
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