| IRB Coordinator -- Buena Park, CA |
Author: Jon Merz
Date: 09-15-09 18:23
IRB Coordinator position at IRB Company Inc.
Work in sunny and beautiful southern California in an exciting and productive environment. We are a growing independent, central IRB in Buena Park (Los Angeles/ Orange County) where you would get creative freedom to perform your job duties. We are looking for a motivated IRB Coordinator with prior IRB experience, who would report to the IRB Manager.
As an IRB coordinator, your main responsibilities would be to review IRB protocols. Most of our protocols are on our web based eProtocol system and we have some legacy protocols on paper where we are planning to migrate those studies to the eProtocol system. You will work under the IRB manager and help manage the day-to-day operations of the IRB including meeting scheduling, facilitating and keeping meeting minutes. We are preparing for our AAHRPP ( www.aahrpp.org ) site visit in early 2010 and you would work closely with Medical Director and IRB manager in implementing new SOPs (Standard Operating Procedures).
Functions and Responsibilities:
1. In collaboration with IRB manager, IRB analysts and Medical Director, coordinates the day to day operations of the IRB; plan and facilitate regular and special meetings of the IRB.
2. Coordinates large scale projects related to the improvement of IRB processes and regulatory compliance, such as implementation of electronic submissions, training and outreach sessions, and development and implementation of IRB policies and procedures.
3. Works with IRB manager and other staff members, IRB Chair and Medical Director, to prepare initial accreditation documents/ site visit preparation, and annual accreditation reports to maintain accreditation.
4. Ensures IRB roster is compliant with OHRP and FDA requirements.
5. Manages communications to Principal Investigators (PI); notifies PIs of IRB decisions, requests additional information when required and coordinates supplementary materials required by the IRB including the preparation and distribution of information.
6. Manages information to support the IRB function including minutes, agendas, and other correspondence. Responsible for working with the IRB manager and other staff in compiling and writing of IRB minutes.
7. Evaluates IRB applications for completeness and conformance to regulations, guidelines and best practices. Alerts IRB Manager, Chair and Medical Director to protocol issues that may need closer review.
8. Maintains IRB files and databases. Generates IRB statistical reports based on databases.
9. Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service.
10. Supports the IRB Manager and Medical Director on IRB related regulatory and assurance issues.
11. Other duties as assigned.
Knowledge, Skills and Abilities:
1. Bachelor’s degree required, Master’s degree in related field preferred.
2. Prior IRB experience in independent IRB or an academic institution. If you do not have prior IRB experience, but have experience in Regulatory setting in academia or industry, you would be considered.
3. Certified IRB Professional (CIP) or CIM (Certified IRB Manager) certificate preferred and if you do not have CIP or CIM certificate, we would expect you to take the exam within two years of joining IRBCO.
4. Possess excellent verbal and written command of the English language.
5. Organizational skills: Good problem solving capability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
6. Demonstrated knowledge of Microsoft Office, Access, Excel, Adobe Acrobat, internet and other computer software is required.
We offer competitive salary and benefits and flexibility in your work schedule is possible. Please email us at careers@irbco.com or call (714)562-0526. More information about IRBCO can be obtained at www.irbco.com .
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Author |
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IRB Coordinator -- Buena Park, CA new |
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Jon Merz |
09-15-09 18:23 |
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