IRB Reliance Coordinator - Office of Human Subjects Protection - Georgetown University

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Requirements

IRB Reliance Coordinator - Office of Human Subjects Protection - Georgetown University

Job Overview

The Institutional Review Board (IRB) Reliance Coordinator is responsible for the management and execution of GU’s IRB reliance activities. As regulatory agencies move forward with single IRB mandates, the Georgetown University IRB needs a dedicated team to executed and manage reliance agreements, which are necessary to comply with the single IRB regulations. Responsibilities include but are not limited to:

• Oversee activities related to institutional responsibilities as outlined in the agreements and/or dictated by federal, state, or local laws and policies
• Assist the Senior IRB and Reliance Coordinator with the development of operational policies, procedures, and growth of the IRB office’s reliance program
• Review IRB reliance requests for appropriateness and engagement of the institutions
• Complete reliance confirmation letters after review
• Complete GU Local IRB review for local consideration compliance
• Execute institutional clearance letter and facilitate execution of reliance agreement as appropriate
• Manage IRB review and acknowledgements of actions for external IRB studies
• Assist in tracking data management related to the reliance operations

Work Interactions and Work Mode Designation

Georgetown’s Office of Human Subject Protections (OHSP) , reporting to the Medical Center Dean for Research and the Vice Provost of Research for the Main Campus, serves as the official oversight office for human subject research activities at Georgetown University.

Reporting directly to the OHSP Senior Director, the IRB and Reliance Coordinator has focused oversight for IRB and reliance activities of the office, and necessarily works well with the OHSP team, the GU research community members, and with other ancillary review offices, such as Conflict of Interest and Radiation Safety.

This position has been designated as 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 website: https://hr.georgetown.edu/mode-of-work-designation .

Requirements and Qualifications

• Bachelor’s degree in an ethics, scientific, engineering or healthcare administrative discipline [note : alternate degree fields will be considered/accepted based upon the nature and depth of the research experience as related to this position]
• At least 2 to 4 years of work experience that provided familiarity with research ethics and methodologies - at least 1 year of work experience that includes 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
• Toward conduct of the IRB review process via an electronic web-based system: comfortable with reading on a screen rather than paper and switching 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
• Strong organization skills in 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

Current Georgetown Employees:

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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 resume for each position of interest for which you believe you are qualified. 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 [email protected] .

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 comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website .