The IRB Reliance Administrator is part of a team that processes human subjects research protocols overseen by the Harvard University Area (HUA) IRB. The IRB Reliance Administrator is primarily responsible for leading the reliance process and negotiating relationships between HUA IRB and outside/external IRBs, including institutional and commercial IRBs. Within the scope of the reliance relationships utilizing the single IRB (sIRB) model, HUA participates as both a relying IRB and reviewing IRB.
The IRB Reliance Administrator is also responsible for carrying a moderate portfolio of IRB reviews as well as administrative support for the convened IRB including the preparation of the IRB meeting agenda and IRB meeting minutes.
He/she will report to the Senior IRB Administrator in the Harvard University-Area IRB office with an indirect reporting line to the Director of IRB Administration.
Duties & Responsibilities
Analyze and review applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and Harvard University-Area IRB guidelines;
Determine whether research projects are exempt from further review, review and approve certain research projects on behalf of the IRB as a designated reviewer;
Correspond with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered;
Demonstrates knowledge-based understanding of the complete IRB review process.
Works independently to lead and offer guidance regarding human subject's research applications submitted to the IRB, with a specific focus on submissions subject to a reliance agreement.
Consults via phone and in-person with HUA investigators inquiring about the reliance agreement process.
Conducts administrative review of designated human subjects research application submissions including verification of training requirements related to sIRB review.
Maintains a working knowledge of HUA IRB procedures, guidelines and policies for all research, and research subject to review under an IRB reliance agreement.
Communicates cede determinations to HUA and external investigators for studies where HUA IRB is the reviewing IRB or a relying institution.
Serves as a HUA IRB liaison for external reliance platforms where reliance determinations may be documented.
Tracks reliance agreements when HUA IRB is the reviewing IRB or relying on an external IRB.
Advises & supports investigators and their staff [both internal and external to the institution] regarding submission of applications in accordance with institutional policy, federal, state, and local regulations governing human subjects research.
Formulates IRB agenda materials and tracks components of the review process, including communication with other offices and committees.
Records IRB meeting minutes in keeping with current policies and procedures. Must be able to accurately and succinctly summarize discussions regarding scientific and regulatory matters pertaining to human subject's research.
Independently prepares appropriate correspondence to document the IRB's decision regarding the review of human subject's research applications.
Develop and participate in training and educational activities on human research protections that are presented to researchers and administrators;
Provide guidance to researchers and administrators on the use of the Electronic Submission Tracking & Reporting (ESTR) system used by the Harvard University-Area IRB to manage applications for review and automate correspondence;
Salary Grade: 056
Union: 00 - Non Union, Exempt or Temporary
Candidates MUST meet the following basic qualifications in order to be considered for this role:
Bachelor's degree with at least 2 -years of experience related to the field of human subjects research protections.
Demonstrated knowledge and understanding of the federal regulations on human research protections.
Demonstrated proficiency in the MS-Office Suite of computer applications.
Strong written and oral communication skills are essential, with demonstrated ability to organize, write about and discuss regulatory and complex issues clearly. The ability to communicate with highly diverse group of people with sensitivity to cultural differences. Proven ability to take initiative and work both independently and as a team member, ability to manage multiple projects simultaneously, and work well under deadlines. Familiarity with electronic database and automation systems strongly preferred. An advanced degree in social or behavioral science, law, or public health is preferred. Experience working in a fast-paced academic research environment and with faculty from various academic disciplines is preferred.
EQUAL OPPORTUNITY EMPLOYER: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: 47579BR
About Harvard University Administration
Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education. Established in 1636, Harvard is the oldest institution of higher education in the United States.