US-PA: Philadelphia-Asst Dir IRB Operations

**************************************************************
JobCircle.com is a regional job board serving all industries
and occupations in the PA, NJ, DE, NY, MD, and DC areas.

We offer a regional job board, online learning, and regional
job fair events for jobseekers who live in our areas of focus.

To Learn More:

Job Board: http://www.JobCircle.com?source=ng
eLearning: http://www.JobCircle.com/courseware?source=ng
Job Fairs: http://JobCircleJobFairs.com?source=ng

**************************************************************

Job Title: Asst Dir IRB Operations
Job Location: PA: Philadelphia
Pay Rate: Open
Job Length: full time
Start Date: 2008-02-26

Company Name: Children's Hospital of Philadelphia
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: Requisition #: 08-13909 Job Title: Asst Dir IRB Operations City: Philadelphia State: Pennsylvania Scheduled Shift: Days Employee Type: Regular - Full Time *Scheduled Days: Monday Tuesday Wednesday Thursday Friday Research Division: Requirements: BA/BS/Masters degree in related field of study required. 5 - 7 years experience IRB experience or equivalent. Management experience. CIP certification required within one year of hire Skills and knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators. Excellent time management and prioritization skills Excellent oral and written communication skills Ability to function independently and as part of a team Team Leadership skills Ability to apply AAHRPP guidelines. Experience in development of educational programs. Job Description: The Assistant Director for Human Subject Research, will be responsible for overseeing the IRB Operations, supporting the IRB Committees and providing educational and developmental training programs on human subject protections for investigators and research staff.

Oversight of IRB Operations IRB Staff Management -Hire, train, and retain IRB Analysts and related support staff -Supervise and manage and ensure the work quality of the IRB Analysts and related support staff -Develop metrics for tracking and setting productivity goals. IRB submissions -Develop and implement IRB submission processes and tracking mechanisms -Assign submissions to IRB Analysts and Committees -Assure efficient procedures for processing submissions from initial intake through approval -In conjunction with the Director, Human Subject Research, provide consultation to investigators and research staff on development of IRB submissions and responses to IRB stipulations. IRB Records -Ensure that all IRB files are maintained as required by regulations and IRB SOPs -Ensure that IRB records are available for outside auditors -Assure timely publication of meeting minutes. -Implementation and maintenance of computerized IRB management system, with a primary focus on: Implementation of IRB office procedures Training of IRB staff Maintenance and updating of forms IRB Operating Procedures -Take primary responsibility for developing and revising IRB standard operating procedures as needed to ensure compliance with Federal regulations and guidelines including but not limited to 45 CFR 46, 45 CFR 164, 21 CFR 50 and 21 CFR 56,State and local law and regulation, CHOP institutional research policies,CHOP Federal Wide Assurance with OHRP, IRB policies Coordinate with other areas of research administration, such as sponsored projects, CTRC and technology transfer, to facilitate processes for common areas of work. IRB Committees -Ensure the proper functioning of the IRB committees and subcommittees in accordance with federal regulations and the IRB SOPs. -Support the IRB Chairs, Vice Chairs and committee members by providing consultation on regulatory issues related to protocol review. -Ensure that the membership of the IRB committees remains appropriate in number, experience, expertise and diversity -Identify and obtain committee consultants as required -Serve as a resource to the IRB committees and the wider research community at CHOP on matters related to IRB function, regulation and protection of human subjects research, and clinical research implementation and oversight. -Maintain and update Federalwide assurance and IRB registrations -Establish and maintain cooperative agreements with outside IRBs Training and Education -In conjunction with Research Education, develop and implement training programs on human subjects protections for investigators and research staff. -Provide consultation to investigators and research staff on development of IRB submissions and responses to IRB stipulations. -Develop orientation and training programs for IRB Committees members and staff. -Maintain training records for IRB staff and committee members -Develop and implement training programs for computerized IRB management system including, but not limited to: educational materials, preparation, maintenance and updating of guidance Budgets and Financial Tracking -In conjunction with Director develop annual budget for the IRB office and committees -Responsible for budget oversight and tracking.

Additional duties: -Assist with AAHRPP Accreditation process -Serve on Stokes Research Institute and CHOP committees as required by the Chair, CPHS and Director, Research Compliance and Regulatory Affairs -Respond to inquiries from both within and outside the Hospital and from both faculty and administrators regarding IRB SOPs, function, organization, training, etc. Other duties as required by the Director -National Committee and Continuing Educational Activities -Develop and maintain contacts with peers at other institutions, monitor on-going national discussions on regulatory and ethical issues. -Continuing Education: attend regulatory, IRB, human subjects protection, compliance conferences as appropriate.




Please refer to Job code chop-13909 when responding to this ad.


For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1170297.html?source=ng to apply online.


**************************************************************
For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
**************************************************************