Senior IRB and Reliance Coordinator, Office of Human Subject Protections – Georgetown University Medical Center

Updated: 4 days ago
Location: Coeur D Alene, IDAHO
Job Type: FullTime

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Requirements

Senior IRB and Reliance Coordinator, Office of Human Subject Protections – Georgetown University Medical Center

Job Overview

The IRB Senior and Reliance Coordinator, under the direction of the Senior Director of the Office of Human Subject Protections (OHSP), provides regulatory expertise, guidance and administrative support to the IRBs reviewing human subject research protocols; and are responsible for the management and execution of GU’s IRB reliance activities. They work directly with the Senior Director to assist in the daily management of the IRB and act as the first point of contact for the GU IRB coordinators; and assist with the development of operational policies, procedures and growth of the IRB office, including those related to reliance agreement and single IRB. 

The Senior IRB and Reliance Coordinator provides training and education on procedures to IRB staff, IRB members, the research community, and others as appropriate. As a result, their extensive understanding of human subject research regulations and federal guidance is critical. They complete their work in accordance with the processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to human subjects in research at Georgetown University. 

Work Interactions

The Office of Human Subject Protections serves as the official oversight office for human subject research activities at Georgetown University; and reports to the Medical Center Dean for Research and the Vice Provost of Research for the Main Campus. The Senior IRB and Reliance Coordinator reports directly to the Senior Director of the Office of Human Subject Protections with focused oversight for IRB and reliance activities of the office; and work collaboratively with the Senior Quality Assurance Auditor and the Office of Research Oversight for compliance or conflicts of interest issues involving human subjects research. They contribute to the supervision of the IRB team, though not in a formal supervisory role; contribute to feedback for the IRB team’s performance evaluation; and assume responsibilities related to IRB oversight in the absence of the Senior Director. Further, they work well with the GU research community members and other ancillary review offices such as radiation safety and biomedical safety.

Qualifications

  • Bachelor’s degree in an ethics, scientific, engineering or healthcare administrative discipline - alternate degree fields will be considered/accepted based upon the nature and depth of the research experience as it relates to this position
  • At least 3 to 5 years’ work experience that provided familiarity with research ethics and methodologies – at least 2 years of that work experience must include  human subjects’ review/oversight; interaction with human subjects as a research staff person; or any position involving the application of complex regulatory systems to individuals and work activities
  • Experience demonstrating highly effective communications skills and ability to work on multiple projects
  • Computer proficiency - including MS Word, Excel, internet browsers, and email
  • Because the IRB review process is conducted via an electronic web-based system, the IRB Senior and Reliance Coordinator must be comfortable reading on a screen rather than paper, as well as to easily switch back and forth between screens to obtain and synthesize information.

Preferred qualifications

  • Certification as an IRB professional (CIP)
  • Comfort with making judgment calls in ambiguous situations
  • Highly organized at tracking and prioritizing work
  • Outstanding attention to detail
  • Ability to write and speak in concise, accurate, and intelligible manner
  • Ability to work independently with minimal supervision
  • Analytical and problem-solving skills
  • Diplomatic and professional interpersonal skills
  • Ability to work well as part of a team in conditions of high volumes and rigid deadlines

Work Mode: Telework. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff and AAP positions can be found on the Department of Human Resources Mode of Work Designation .

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here  for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu .

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer  fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law .

Benefits:

Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu  or view the online interactive benefits guide  for more information.


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