Employment Status:AF - Active - Regular - Full Time
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 IRBs 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 Assistant Director, IRB Operations. The IRB Analyst I may be assigned to work under the direction of an IRB Analyst III. Analysts help ensure that the Hospitals 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.
- Maintain a current understanding and knowledge of federal and state regulations, state and local law, and CHOP IRB SOPs.
- Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects.
- Responsible for the ensuring timely processing, pre-review and disposition of assigned protocols, modifications, continuing reviews, unanticipated problems involving risks to subjects or others, and investigator responses.
- Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs.
- Prepare agenda and minutes for committee meetings in accordance with SOPs.
- Work closely with, and in support of, the respective IRB Chair, Vice Chairs, reviewers and other members.
- Participate in all relevant institutional research educational activities related to human subjects protections and IRB operations.
- Maintain and ensure retention of all required IRB records, communications and other documents.
- Assist in the coordination of IRB activities with other CHOP Divisions and Departments.
- Provide education and training on use of IRB electronic management system with the research community.
- Timely communication with investigators/designees regarding IRB submissions.
- Assists on special projects as needed.
Job Responsibilities (Continued)
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
BA/BS degree (biology, psychology or other clinical research-related area) required; equivalent combination of experience and education will be considered.
- Minimum of 1 year 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
Preferred Education, Experience & Cert/Lic
Masters or other advanced degree preferred;
Additional Technical Requirements
- 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
- Knowledge of clinical research and familiarity with medical terminology
- Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies for discussion with the Committee and/or Committee Chair.
- Excellent written and oral communications skills.
- Demonstrated ability to work as a team member
- Ability to work effectively with individuals at all levels of the organization.
- 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
- Familiarity MS Word required and experience with computerized databases helpful.
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• Post ID: 40321948 philadelphia