Reading Hospital
DIRECTOR HUMAN SUBJECT PROTECTIONS
At a glance
Location: US-PA-Reading Map
Posted: 11/17/2020
Closing: 12/16/2020
Degree: Not Specified
Type: Full-Time
Experience: At least 2 year(s)
Reading Hospital
Job description

Advancing Health. Transforming Lives.

Tower Health is a strong, regional, integrated healthcare system that offers leading-edge, compassionate healthcare and wellness services across Eastern Pennsylvania. We bring together more than 11,000 dedicated team members, including 2,000 nationally recognized physicians, specialists, and providers across 65 convenient locations. Together, our six hospitals and other entities offer a full range of medical care to the communities we serve. Here, we know that advancing the quality of care will transform the quality of life.

 

About Reading Hospital

Our nationally recognized flagship institution, Reading Hospital has served the local community since 1867. We’re a Magnet® designated facility with many specialties, a dedicated rehabilitation hospital, and affiliated medical offices, all committed to delivering access to the region’s highest quality care, leading-edge technology, and experienced medical professionals. Located in the friendly West Reading area, our main campus offers a variety of amenities that make working here every day a pleasure.



Responsibilities

The Director of Human Subject Protections is knowledgeable of federal, state, local and institutional regulations enabling coordination of and responsibility for all Institutional Review Board functions to assure protection of human research participants.  The Director of Human Subject Protections is responsible to:

  • Establish and utilize IRB resource library.
  • Obtain and maintain Federalwide Assurance and IRB Registration with the Office of Human Research Protections at the U.S. Department of Health and Human Services.
  • Establish auditing procedure for informed consent process.
  • Participate in the review and disposition of matters of actual or potential non-compliance.
  • Perform expedited review in compliance with applicable regulations and policies. Requests consultant review of proposed or approved studies if
    required.
  • Establish and implement a continuing quality assurance program.
  • Develop basic guidelines and information for new members and principal investigators.
  • Develop a continuing education program for committee members and principal investigators.
  • Develop, maintains and administers standard operating procedures (SOP's) for all aspects and functions of the IRB to assure compliance with pertinent
    regulations.
  • Perform expedited review in compliance with applicable regulations and policies.
  • Request consultant review of proposed or approved studies if required.
  • Act as resource for federal, state, local and institutional regulations pertaining to human research activities.
  • Maintain current knowledge of federal, state and local laws, regulations and guidelines governing human subject research.
  • Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants.
  • Attend educational and professional seminars as dictated by relevant certification standards.
  • Act as a liaison with federal and state agencies on human research issues.
  • Serve as the Human Protections Administrator on the Tower Health Federalwide Assurance (FWA).
  • Provide advice, guidance and problem resolution to research investigators and support personnel in the application of relevant federal, state and local
    regulations and guidelines.
  • Participate in review of request for determination of Exempt from IRB oversight.
  • Attend monthly IRB meetings.
  • Generate detailed minutes adhering to federal criteria.
  • Create correspondence in compliance with the dictates of the committee.
  • Administer processing of all IRB documents.
  • Establishes agenda.
  • Conduct primary review of all items submitted for review by the committee.
  • Administer receipt, assignment, processing, review, tracking and file maintenance for all submitted information related to human research.

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Qualifications

EDUCATION REQUIREMENTS

  • Master’s Degree

EXPERIENCE

  • 2+ years related experience

CERTIFICATION AND LICENSURE REQUIREMENTS

  • Certified IRB Professional within 2 years of hire

REQUIRED SKILLS

  • Excellent Communications Skills
  • Excellent Interpersonal Skills
  • General Clerical Skills
  • Microsoft Excel, Word, PowerPoint & Outlook
DIRECTOR HUMAN SUBJECT PROTECTIONS