| IRB Coordinator -- Buena Park, CA |
Author: Jon Merz
Date: 12-11-11 08:33
Position Title: IRB Coordinator
Position reports to: IRB Manager/Administrative Director, IRBCo.
Located in: Buena Park
As an IRB coordinator, your main responsibilities would be to review study submissions for completeness and prepare correspondence with clients and the
Board. Most of our protocols are on our web based eProtocol system and we have some legacy protocols on paper which will be migrated soon (to the web based system). You will work under the direct supervision of IRB Manager and help manage the day-to-day operations of our full board review submissions.
Essential 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. Must have strong understanding of company SOP's and their application.
12. Communicates via electronic mail acknowledging and sending corresponding in a professional, courteous manner.
13. Other duties as assigned.
Knowledge, Skills and Abilities:
1. Bachelor's degree required; Master's degree preferred.
2. Prior experience with our web based electronic system - called eProtocol (eP) a huge plus; but not required.
3. Prior IRB or other clinical research experience required.
4. Certified IRB Professional (CIP) certificate preferred; if you do not have CIP certificate, you would be expected to take the exam within two years of joining IRBCo.
5. Possess excellent verbal and written command of the English language.
6. Organizational skills: Good problem solving capability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
7. Demonstrated knowledge of Microsoft Office, Access, Excel, Adobe Acrobat, internet and other computer software is required.
8. Requires strong verbal, written, organizational, interpersonal, and team-oriented skills. The ability to organize and prioritize work and perform several tasks simultaneously to meet deadlines is essential.
9. Has the ability to deal effectively with people at all levels, including upper management.
To apply for this position, please email a Word/PDF copy of your cover letter and CV/resume: to Urvashi Arora, IRB Manager & Admin. Director, IRBCo - uarora@irbco.com.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be constructed as an exhaustive list of all responsibilities, The company is a dynamic work environment where positions evolve and change. Therefore, The Company reserves the rights to modify, delete, or add job duties, responsibilities and skills that are stated in this job description at any time.
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Author |
Date |
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IRB Coordinator -- Buena Park, CA new |
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Jon Merz |
12-11-11 08:33 |
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