The Children's Hospital of Philadelphia
Deadline: May 19, 2015
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.
Child Abuse Clearances
FBI Fingerprint Clearance
The Children's Hospital of Philadelphia has a position available within the Department of Human Subjects Research (IRB Office) as an IRB Analyst I.
The IRB Analyst I is responsible for staffing the Committee for the Protection of Human Subjects (CPHS) and its Institutional Review Boards (IRB). They help ensure that the IRB’s work is accomplished in a timely manner. The IRB Analyst-I works closely with the Chair CPHS, the IRB Chairs and Vice Chairs and reports to directly to the Director, Human Subjects Research. The IRB Analyst I may be assigned to work under the direction of an IRB Analyst II. Analysts help ensure that the Hospital’s clinical research activities are conducted in compliance with institutional SOPs and international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research. They ensure that research activities at the Hospital involving human subjects are conducted in a manner that protects the safety, rights, and welfare of participants.
1. 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
2. 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
- 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
- IRB Files
- 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
3. Contacts with others
- 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.
4. 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
Interested candidates would need to apply on the CHOP website.job public health research