Asst Dir Compl/Reg Aff IRB Ops:
CHOP

24751-en_US
CHOP
Philadelphia Pennsylvania
Healthcare
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Description

Req ID: 24751

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

The Associate Director, Research Compliance & Regulatory Affairs - IRB Operations has primary responsibility for the operations of the IRB Office including staff supervision, processing of IRB submissions, maintenance of IRB records, budgetary oversight, and development of standard operating procedures.

Job Responsibilities

  1. IRB Operations

 

  1. IRB Staff Management
    1. Hire, train, and retain IRB Analysts and related support staff
    2. Supervise and manage and ensure the work quality of the IRB Analysts and related support staff
    3. Develop metrics for tracking and setting productivity goals.

 

  1. IRB submissions
    1. Develop and implement IRB submission processes and tracking mechanisms
    2. Assign submissions to IRB Analysts and Committees
    3. Assure efficient procedures for processing submissions from initial intake through approval
    4. In conjunction with the Director, Human Subject Research, provide consultation to investigators and research staff on development of IRB submissions and responses to IRB stipulations.

 

  1. IRB Records
    1. Ensure that all IRB files are maintained as required by regulations and  IRB SOPs
    2. Ensure that IRB records are available for outside auditors
    3. Assure timely publication of meeting minutes.

 

  1. Coordinate with other areas of research administration, such as sponsored projects, CTRC and technology transfer, to facilitate processes for common areas of work.

 

  1. Budgets and Financial Tracking
    1. In conjunction with Director, Office of Research Compliance & Regulatory Affairs develop annual budget for the IRB office and committees
    2. Responsible for budget oversight and tracking.

 

  1. IRB Operating Procedures

Take primary responsibility for developing and revising IRB standard operating procedures as needed to ensure compliance with

  1. Federal regulations and guidelines including but not limited to 45 CFR 46, 45 CFR 164, 21 CFR 50 and 21 CFR 56
  2. State and local law and regulation
  3. CHOP institutional research policies
  4. CHOP Federal Wide Assurance with OHRP
  5. IRB policies

 

  1. Assist Director, Human Subjects Research with implementation and maintenance of computerized IRB management system, with a primary focus on:
    1. Implementation of IRB office procedures
    2. Training of  IRB staff
    3. Maintenance and updating of forms

 

  1. Additional duties:
    1. Assist with AAHRPP Accreditation process
    2. Serve on Stokes Research Institute and CHOP committees as required by the Chair, CPHS and Director, Research Compliance and Regulatory Affairs
    3. Respond to inquiries from both within and outside the Hospital and from both faculty and administrators regarding IRB SOPs, function, organization, training, etc.
    4. Other duties as required by  the Director, Research Compliance and Regulatory Affairs

 

  1. National Committee and Continuing Educational Activities
    1. Develop and maintain contacts with peers at other institutions, monitor on-going national discussions on regulatory and ethical issues.
    2. Continuing Education - Attend regulatory, IRB, human subjects protection, compliance conferences as appropriate

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

CIP - CIP

Required Education and Experience

  • BA/BS/Masters degree in related field of study required.

  • 5 - 7 years experience IRB experience or equivalent.

  • Management experience.

Preferred Education, Experience & Cert/Lic

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.

  • Excellent time management skills and writing ability

  • Understanding of federal research regulations, OHRP and AAHRPP guidelines. Experience in development of educational programs.

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:[email protected]

 

 

Basic Qualifications
Requirement