| Manager, QA and Regulatory Compliance -- San Diego, CA |
Author: Jon Merz
Date: 10-14-09 15:54
Aspire IRB provides full IRB review services to the research community nationwide. Aspire IRB can manage your central and local IRB needs efficiently and professionally. The staff of Aspire IRB have more than 50 years of IRB experience and place customer service as a top priority.
Aspire is committed to the highest level of human research protection. To demonstrate its commitment, Aspire has achieved FULL accreditation from AAHRPP.
Our mission is to protect human subjects while developing and nurturing a personal relationship with our client.
Aspire IRB is looking for an individual for the position of Manager, QA and Regulatory Compliance. This person will be responsible for the regulatory compliance of Aspire IRB. Responsible for the continual training and updating of staff and members; Development and updating of the Aspire IRB SOP; Acts as the main point of contact for all audits.
Essential Duties and Responsibilities include the following. Other duties may be assigned as needed:
* Performs quality assurance audits and record management.
* Updates (at least annually) and training of all staff, IRB Members, consultants and auditors
* Develop, review, maintain and archive comprehensive IRB minutes and documents concerning IRB functions and meetings; Attend IRB meetings
* Maintains satisfactory performance in audits from Sponsors, OHRP, FDA or clients; Development, update as necessary and implement procedures for managing and responding to these types of audits
* Provides leadership and direction to the staff, clients and Board members of the IRB. Assists in board membership application, selection, and record management of their respective qualifications and training
* Represent the IRB at professional, community and internal meetings
* Coordinate and engage outside auditors to complete audit functions for the IRB
* Along with consultants and legal counsel maintain and update IRB information concerning Federal Regulations, guidelines, information sheets, applicable state and local laws and Aspire SOP’s regarding human subject research.
* Coordinate and prepare appropriate paperwork, maintain correspondence concerning applications and updates for the IRB Registrations and/or Filings
* Responsible for maintaining the accreditation of Aspire IRB
* Promote and support staff and IRB member certification
* Responsible for managing subject complaints
* Develop training program for staff, IRB members, consultants and auditors; create and maintain training files.
* Experience with International research
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform job duties and functions.
Education and/or Experience:
Bachelors degree required; or 5-7 years of related regulatory experience/IRB and/or training; or equivalent combination of education and experience.
Computer Skills:
To perform this job successfully, an individual should have knowledge of database software; internet software; MS Publisher; Microsoft Office products.
Certificates, Licenses, Registrations and other skills and qualifications:
CIP or CIM certification preferred
To perform this job successfully, an individual shall demonstrate competency in the following skill sets:
Problem solving
Project management
Technical skills
Customer service
Interpersonal skills
Oral communication
Written communication
Teamwork
Organizational Support
Judgment
Motivation
Professionalism
Quality Management
Attendance/punctuality
Dependability
Initiative
Qualified applicants may apply for this position via fax to 619-797-1239 or email@aspire-irb.com attn: HR Director; please include your cover letter, resume and salary requirements. We offer competitive salary and benefits and a positive corporate culture.
More information about Aspire IRB can be seen on our website: www.aspire-irb.com
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Author |
Date |
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Manager, QA and Regulatory Compliance -- San Diego, CA new |
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Jon Merz |
10-14-09 15:54 |
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