Nationwide Children's Hospital

IRB Specialist II - RI Scientific

Posted Date 2 months ago(8/13/2020 1:28 PM)
Requisition ID
2020-24782
Category
Research

Overview

IRB Specialist II- RI Scientific

Full Time; Benefit Eligible

 

We are seeking an IRB Specialist II-  the primary responsibility is for staffing the Institutional Review Board (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 Specialist I and other support staff, and for serving as a consultant to clinical investigators at NCH. The IRB Specialist II works closely with the IRB Chair and Vice Chair and reports to directly to the Human Research Protection Program Director. Specialists 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.

Responsibilities

 

Why Nationwide Children's Hospital?

The moment you walk through our doors, you can feel it. When you meet one of our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it, too. Welcome to Nationwide Children’s Hospital, where Passion Meets Purpose.

Here, Everyone Matters. We’re 13,000 strong. And it takes every single one of us to improve the lives of the kids we care for, and the kids from around the world we’ll never even meet. Kids who are living healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children’s Hospital. A Place to Be Proud.

 

What Will You Be Doing?

 

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 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. 

 

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 IRB Chair, Vice Chair, reviewers and other members.

• Participate in all relevant institutional research educational activities related to human subject protections and IRB operations.

• Maintain and ensure retention of all required IRB records, communications and other documents. 

Contacts with others

• Assist in the coordination of IRB activities with other 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. 

Assist on special projects as required

• Perform Quality Assurance Reviews of Specialists I’s work and provides constructive feedback.

• Assists on special projects as needed.

• Lead institutional research educational activities related to IRB expertise and human subject 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.

Qualifications

What Are We Looking For?

To fulfill this role successfully, you must possess these minimum qualifications and experience

  •  Required Licenses/certificates/registrations None. CIP Encouraged. 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 human subject protection-related job. Direct and obvious relevance to regulatory compliance and research with human subjects 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; experience with computerized databases and MS Windows operating system environment helpful.

Your Benefits, Your Wellness:

As an employer, Nationwide Children’s recognizes the importance of the benefits we offer. We also recognize the importance of balancing your work and personal needs. Our benefits and Employee Wellness package is designed to:

  • Empower you to be a conscientious health care consumer through educational and wellness activities
  • Establish a work environment that promotes health and well-being
  • Support your financial protection and security in retirement 
  • Most of our positions are benefits’ eligible from day 1.

Minimum Physical Requirements:

 

  • Sitting Constantly (67-100%)
  • Talking on phone/in person constantly (67-100%)
  • Typing on a keyboard occasionally (0-33%)
  • Standing/walking occasionally (0-33%) The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.  

 EOE/M/F/Disability/Vet

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