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IRB Analyst II

Philadelphia, PA, US, 19146

Job Type: 

Req ID: 26505

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

The IRB Analyst II is responsible for staffing the Committee for the Protection of Human Subjects (CPHS) and its Institutional Review Boards (IRB); for ensuring that the IRB’s work is accomplished in a timely manner, for conducting expedited reviews as a designee of the IRB Chair, for assisting IRB Analyst I and other support staff, and for serving as a consultant to clinical investigators at CHOP. The IRB Analyst II works closely with the Chair CPHS, the IRB Chairs and Vice Chairs and reports to directly to the Assistant Director, IRB Operations. Analysts help ensure that the Hospital’s clinical research activities are 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.

Job Responsibilities
1. Human Subjects Protection: Compliance and Oversight 
  • Assist in the processing of complex compliance concerns. 
  • Maintain a current understanding and knowledge of federal and state regulations, state and local law, and CHOP IRB SOPs. 
  • Serve as a consultant to the IRB membership and the institution on matters related to IRB procedures and applicable federal regulations. 
  • Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects. 
 
2. IRB Operations: Provide IRB Support by performing the following tasks:
  • Perform IRB reviews as a Designee of the IRB Chair. 
  • 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. 
 
3. Contacts with others
  • 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. 
 
4. Assist on special projects as required
  • Perform Quality Assurance Reviews of Analysts I’s work and provides constructive feedback. 
  • Assists on special projects as needed. 
  • Lead institutional research educational activities related to IRB expertise and human subjects protections. 
  • Represent the Office in relevant forums in the Hospital. 
  • Design and maintenance of IRB electronic management system. 
  • Assist in training of new IRB office personnel.
Required Education and Experience
  • BA/BS degree (biology, psychology or other clinical research-related area) required; Masters or other advanced degree preferred; equivalent combination of experience and education will be considered.

  • Minimum of 4 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
Preferred Education, Experience & Cert/Lic

CIP Encouraged.

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.

•  Ability to provide effective leadership to work group.

•  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; 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 are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

CHOP Careers Contact 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

Phone: 866-820-9288 

Email:TalentAcquisition@email.chop.edu

 

 

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