| IRB Analyst II -- Philadelphia, PA |
Author: Jon Merz
Date: 07-13-11 18:20
A position is available within the Department of Human Subjects Research (IRB Office) as an IRB Analyst II. This position will have responsibility for Human Subjects Protection (including submission analysis, compliance, and oversight) and IRB Operations (including communication with Principal Investigators in the Research Institute and other institutions) as well as other duties falling under the IRB.
JOB SPECIFIC RESPONSIBILITIES:
Human Subjects Protection: Compliance and Oversight
* Maintain a current understanding and knowledge of federal and state regulations, state and local law and CHOP IRB SOPs
* Participate within the scope of their knowledge and experience in institutional research educational activities related to IRB expertise and human subjects protections
* Assist in the identification, recruitment and appointment of new IRB committee members
* Assist in the coordination of IRB activities with other CHOP and University committees and research administrative offices
* Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects
* Help ensure appropriate legal input into IRB activities
* Develop and maintain contacts among peers at other institutions, monitor on-going national discussions on regulatory and ethical issues
Communications
* Function as a liaison within and between the IRB committees, investigators and their designees, and Research Compliance and research administrative staff
* Communicate and consult with investigators or their designees related to clinical research protocol matters
* Participate in all relevant institutional research educational activities related to human subjects protections and IRB operations
* Attend professional meetings for the Office, as appropriate and necessary.
Committee Operations:
* The Analyst I will work with other Analysts, usually under the direction of one or more Analyst II staff to provide all necessary support for IRB functions, including the following:
* Protocol Processing: responsible for the ensuring timely processing, review and disposition of assigned protocols
* Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs
* Ensure timely processing of protocols eligible for review using expedited procedures
* Provide instruction and advice to faculty, staff and student researchers on the regulations and on preparation of applications.
* Provide timely follow-up on IRB requests and correspondence to assure compliance
* Meetings Preparation and Reporting
* Prepare preparation of agenda for committee meetings in accordance with SOPs.
* Prepare and distribute meeting minutes for comments after the meeting in accordance with SOPs and accepted timelines.
* Correspond with investigators to provide the outcome of committee determinations and stipulations in accordance with accepted timelines
* Review investigator responses to IRB Stipulations and determine the adequacy and completeness of investigator responses, requesting additional material or information in order to address concerns.
* Work closely with, and in support of, the respective IRB Chair, Vice Chairs, reviewers and other members
* IRB Files
* Responsible for ensuring the timely notification, processing, review and disposition of all continuing review activities including: unanticipated problems related to research, protocol amendments, protocol deviations and continuing review reports
* Enter specified data from new applications and all subsequent protocol events information in the IRB Database/ Management System.
* Responsible for the maintenance and retention of all required IRB records, communications and other files
Assists on special projects as required
* Education and training on use of IRB electronic management system
* Activities related to attaining or maintaining IRB AAHRPP accreditation
EDUCATION & EXPERIENCE
* BA/BS degree (biology, psychology or other clinical research-related area) or equivalent experience required.
* Minimum of 2 years of experience in IRB administration, clinical research or other humans subjects protection-related job. Direct and obvious relevance to regulatory compliance and research with human subjects
KNOWLEDGE, SKILLS & ABILITIES
* Basic skills and knowledge of federal regulations pertaining to research, ICH GCP, and HIPAA
* Basic knowledge of clinical research and familiarity with medical terminology
* Excellent written and oral communications skills.
* Excellent time management skills with ability to independently prioritize, organize and efficiently deal with a multiple ongoing activities
* Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks
* Ability to work as an effective team member
* Familiarity MS Word required; experience with computerized databases and MS Windows operating system environment helpful.
All CHOP employees who work in a patient building or who provide patient care/work with human subjects in clinical trials are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
To apply, please visit http://jobs.chop.edu/philadelphia/audit-and-compliance/jobid1585319-irb-analyst-ii-jobs
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| Topics |
Author |
Date |
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IRB Analyst II -- Philadelphia, PA |
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Jon Merz |
07-13-11 18:20 |
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