Georgetown University
IRB Reliance Coordinator - Office of Human Subject Protections, Georgetown Unive
Georgetown University, Washington, District of Columbia, us, 20022
IRB Reliance Coordinator - Office of Human Subject Protections, Georgetown UniversityLocated in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight-knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.Job Overview
The Office of Human Subject Protections serves as the official oversight office for human subject research activities at Georgetown University. The IRB Reliance Coordinator reports directly to the Senior IRB and Reliance Coordinator of the Office of Human Subject Protections.Under the direction of the Senior IRB and Reliance Coordinator, the 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 execute and manage reliance agreements, which are necessary to comply with the single IRB regulations. The IRB Reliance Coordinator will oversee activities related to institutional responsibilities as outlined in the agreements and/or dictated by federal, state, or local laws and policies. Additionally, the IRB Reliance Coordinator will assist the Senior IRB and Reliance Coordinator with the development of operational policies, procedures, and growth of the IRB office's reliance program.Key Responsibilities
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 acknowledgments of actions for external IRB studies.Assist in tracking data management related to the reliance operations.Draft agreements using established templates.Ensure fully executed agreements are filled in the IRB system and notify researchers of final determinations.Requirements and Qualifications
Bachelor's degree required in an ethics, scientific, engineering, or healthcare administrative discipline. Alternate degree fields will be considered based on the nature and depth of the research experience as it relates to this position.A minimum of 2-4 years' work experience providing familiarity with research ethics and methodologies. A minimum of one year 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.Experience demonstrating highly effective communication skills and ability to work on multiple projects.Computer proficiency is required, including MS Word, Excel, internet browsers, and email. The IRB review process is conducted via an electronic web-based system, requiring comfort with reading on a screen and synthesizing information across multiple screens.Preferred Requirements
Certification as an IRB professional (CIP) is a benefit.The qualities of the successful candidate will include: (1) comfort with making judgment calls in ambiguous situations; (2) highly organized at tracking and prioritizing work; (3) outstanding attention to detail; (4) ability to write and speak in a concise, accurate manner; (5) ability to work independently with minimal supervision; (6) analytical and problem-solving skills; (7) diplomatic and professional interpersonal skills; and (8) ability to work well as part of a team in high-volume and rigid deadline conditions.Work Mode Designation
This position has been designated as Telework. Please note that work mode designations are regularly reviewed to meet the evolving needs of the University.Pay Range
The projected salary or hourly pay range for this position is: $47,586.00 - $87,558.13. Compensation is determined by factors including the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.Submission Guidelines
Please note that to be considered for any position at Georgetown University, you must submit a resume for each position of interest. 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 .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, disability status, protected veteran status, or any other characteristic
protected by law .Benefits
Georgetown University offers a comprehensive and competitive benefits 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.To apply, visit
https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/IRB-Reliance-Coordinator---Office-of-Human-Subject-Protections--Georgetown-University_JR18554
#J-18808-Ljbffr
The Office of Human Subject Protections serves as the official oversight office for human subject research activities at Georgetown University. The IRB Reliance Coordinator reports directly to the Senior IRB and Reliance Coordinator of the Office of Human Subject Protections.Under the direction of the Senior IRB and Reliance Coordinator, the 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 execute and manage reliance agreements, which are necessary to comply with the single IRB regulations. The IRB Reliance Coordinator will oversee activities related to institutional responsibilities as outlined in the agreements and/or dictated by federal, state, or local laws and policies. Additionally, the IRB Reliance Coordinator will assist the Senior IRB and Reliance Coordinator with the development of operational policies, procedures, and growth of the IRB office's reliance program.Key Responsibilities
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 acknowledgments of actions for external IRB studies.Assist in tracking data management related to the reliance operations.Draft agreements using established templates.Ensure fully executed agreements are filled in the IRB system and notify researchers of final determinations.Requirements and Qualifications
Bachelor's degree required in an ethics, scientific, engineering, or healthcare administrative discipline. Alternate degree fields will be considered based on the nature and depth of the research experience as it relates to this position.A minimum of 2-4 years' work experience providing familiarity with research ethics and methodologies. A minimum of one year 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.Experience demonstrating highly effective communication skills and ability to work on multiple projects.Computer proficiency is required, including MS Word, Excel, internet browsers, and email. The IRB review process is conducted via an electronic web-based system, requiring comfort with reading on a screen and synthesizing information across multiple screens.Preferred Requirements
Certification as an IRB professional (CIP) is a benefit.The qualities of the successful candidate will include: (1) comfort with making judgment calls in ambiguous situations; (2) highly organized at tracking and prioritizing work; (3) outstanding attention to detail; (4) ability to write and speak in a concise, accurate manner; (5) ability to work independently with minimal supervision; (6) analytical and problem-solving skills; (7) diplomatic and professional interpersonal skills; and (8) ability to work well as part of a team in high-volume and rigid deadline conditions.Work Mode Designation
This position has been designated as Telework. Please note that work mode designations are regularly reviewed to meet the evolving needs of the University.Pay Range
The projected salary or hourly pay range for this position is: $47,586.00 - $87,558.13. Compensation is determined by factors including the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.Submission Guidelines
Please note that to be considered for any position at Georgetown University, you must submit a resume for each position of interest. 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 .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, disability status, protected veteran status, or any other characteristic
protected by law .Benefits
Georgetown University offers a comprehensive and competitive benefits 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.To apply, visit
https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/IRB-Reliance-Coordinator---Office-of-Human-Subject-Protections--Georgetown-University_JR18554
#J-18808-Ljbffr