At UPMC, we are committed to keeping our communities safe and healthy as the COVID-19 pandemic unfolds. Visit upmc.com/vaccinesupport to learn more about how you can help.

Our recruiters will continue to fill positions throughout this time, but interviews and other processes may be modified to protect the safety of our candidates and employees. Thank you for your patience.

For more information about UPMC's response to COVID-19, please visit upmc.com/coronavirus.

Search Our Jobs

   Current UPMC employees must apply in HR Direct

Global IRB & Regulatory Coordinator

Description

Purpose:
This position will provide senior administrative and programmatic support and direction to the Alzheimer's Biomarker Consortium Down Syndrome (ABC-DS) project, a large, multicenter international research effort supported by the National Institute on Aging. The Global IRB & Regulatory Coordinator will be responsible for overseeing the administration and coordination of institutional review board and regulatory operations across multiple performance sites. The Global IRB & Regulatory Coordinator will liaise with investigators and research staff at 16 universities in the United States and the United Kingdom to ensure that IRB human subjects research submissions and federal regulatory documents are available and current, that institutional review board submissions are correctly completed and submitted, and all necessary documentation is available for annual federal reports, IRB reports and meetings. This role will also assist in planning efforts as required by the ABC-DS administrative core team, and will work closely with the Project Global Coordinator, regulatory staff, and other staff as needed. The position reports to the Principal Investigator of the ABC-DS Project.

This position is grant funded.

Responsibilities:
  • Ensures all federal and institutional IRB regulations are met across all performance sites
  • Assists with the development of a uniform ABC-DS IRB submission for use at all performance sites including study protocol, informed consents, phone screens, and recruitment materials, advertisements, newsletters and other documents
  • Tracks submissions as required including protocol amendments and annual continuing reviews
  • Assists in the development of administrative policies and procedures for the operation of ABC-DS that are consistent with institutional, DHHS and IRB requirements and regulations
  • Tracks and assists all performance sites with the processing of approved IRB materials
  • Ensures compliance with all federal and institutional regulations regarding research participant documentation and record keeping
  • Collects and ensures the following are obtained from all performance sites: Licenses, CVs, Human Subjects Training certificates, FDA submissions including Investigational New Drug documentation and other relevant and required regulatory documents
  • Assists performance sites with development and maintenance of regulatory binders
  • Ensures human research participant issues are addressed in an appropriate and timely manner
  • Assists with the writing of bi-yearly DSMB reports, the collection of documents for ABC-DS related grants and supplements such as Bio-sketches, Other Support, annual NIA progress reports and the development of the Human Subjects section of new grant applications and other administrative tasks as required
  • Participates in regular meetings of research staff to facilitate the exchange of information and the resolution of any problems in the implementation of study goals
  • Ensures that study-related administrative and scientific manuals are periodically updated to reflect current information about program studies and operations

Qualifications

  • Masters degree in the social sciences, public health or related field AND at least three to five years relevant research and administrative experience in a University-based or academic health center setting OR Bachelor's degree in the social sciences, public health or related field AND at least five to seven years relevant research and administrative experience in a University-based or academic health center setting
  • Prior interdisciplinary, multi-site research experience with individuals with developmental disorders highly preferred
  • Experience with Institutional Review Board submissions required
  • Experience with federal regulatory requirements for study highly preferred
  • Excellent verbal and written communication skills and interpersonal skills required
  • Excellent organizational skills required
  • Computer literacy in various software applications, including MS WORD, Excel video conferencing and network email applications is required
  • Must be able to work collaboratively and independently to achieve study goals
Licensure, Certifications, and Clearances:
  • Act 34
UPMC is an Equal Opportunity Employer/Disability/Veteran

Total Rewards

More than just competitive pay and benefits, UPMC’s Total Rewards package cares for you in all areas of life &emdash; because we believe that you’re at your best when receiving the support you need: professional, personal, financial, and more.

Our Values

At UPMC, we’re driven by shared values that guide our work and keep us accountable to one another. Our Values of Quality & Safety, Dignity & Respect, Caring & Listening, Responsibility & Integrity, Excellence & Innovation play a vital role in creating a cohesive, positive experience for our employees, patients, health plan members, and community. Ready to join us? Apply today.

   Current UPMC employees must apply in HR Direct