Through its Clinical and Translational Science Awards (CTSA), the National Center for Advancing Translational Science (NCATS) funded a Harvard Catalyst project (SMART IRB) to streamline Institutional Review Board (IRB) review through the development of a national single IRB model from 2014 to the present. This first phase of the project led to the development of a master IRB agreement, standard operating procedures (SOPs) in support of that agreement, and initial work on informatics platforms in support of joining the agreement and reliant review (https://smartirb.org). NCATS recently committed additional funds to Harvard University to continue work on the national SMART IRB model.
The Associate Director of Regulatory Affairs Operations SMART IRB will report to the Harvard Catalyst Director of Regulatory Affairs Operations, with strategic project guidance from the Director of Regulatory Policy/Program Leader (a senior member of the HMS faculty) and the Director of SMART IRB Operations, and work as part of a cross-SMART IRB institutional team. The Associate Director will interact effectively and productively with stakeholders across the nation and therefore should have a high executive function and excel at consensus building. The candidate should have significant experience with human subjects research protections and regulations and IRB operations specifically. The candidate should possess a high level of experience and comfort working independently with senior leaders, faculty, administrators, medical professionals, and officials of external agencies.
The Associate Director will manage multiple project teams and assure performance of defined project tasks are within budget, on schedule, within scope, and of high quality. S/he will oversee several team meetings, including setting agendas and summarizing follow-up, along with monitoring project milestones, collection of interim analytics, and executing the reporting process. The Associate Director will be responsible for SMART IRB-related communication and education on the national level. This includes but is not limited to contributing to the development of materials, webinars, and communication and education for national IRB staff, IRB members, SMART IRB Ambassador-led and SMART IRB Team- led training sessions and assisting with drafting and developing content for SMARTIRB.org (and related online tools and resources). Duties may also include promoting and facilitating SMART IRB events and meetings to ensure timely communications with participating groups as well as initiate program improvement through on-going assessment and evaluation.
The Associate Director must have the ability to manage multiple concurrent deliverables in a fast-paced
environment. In addition to outstanding written and oral communication skills, the candidate must have strong interpersonal skills, as the position requires sensitive collaboration with both academic and government stakeholders. The candidate must be highly organized and able to work on teams as well as independently with limited supervision.
The Associate Director must have and maintain an in-depth knowledge of changing federal, state and local regulations and organizational policies pertaining to human research subject protections to assure that SMART IRB reliance agreement, policies, and processes are in compliance with Federal and State regulations and policies. The Associate Director will work with legal counsel and leadership to strategize and implement necessary changes to the existing agreement to comply with regulations.
This position is supported by a grant that ends on September 30, 2020, with strong potential for renewal.
Harvard offers an outstanding benefits package including:
Time Off: 3 - 4 weeks paid vacation, paid holiday break, 12 paid sick days, 11.5 paid holidays, and 3 paid personal days per year.
Medical/Dental/Vision: We offer a variety of excellent medical plans, dental & vision plans, all coverage begins as of your start date.
Retirement: University-funded retirement plan with full vesting after 3 years of service.
Tuition Assistance Program: Competitive tuition assistance program, $40 per class at the Harvard Extension School and discounted options through participating Harvard grad schools.
Transportation: Harvard offers a 50% discounted MBTA pass as well as additional options to assist employees in their daily commute.
Wellness options: Harvard offers programs and classes at little or no cost, including stress management, massages, nutrition, meditation, and complementary health services.
Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.
The Harvard Medical School is not able to provide visa sponsorship for this position.
Salary Grade: 057
Union: 00 - Non Union, Exempt or Temporary
B.S. or B.A., seven + years of administrative or project management experience preferably in an academic or health care setting.
Excellent interpersonal skills and communication skills are essential. Excellent organizational and writing skills. Advanced degree and IRB Professional (CIP) or CIM (Certified IRB Manager) certificate preferred. Experience with IRB reliance agreements and online reliance systems
preferred. Previous experience using the SMART IRB Reliance Agreement strongly preferred. Direct IRB-related experience (i.e., experience as an IRB director, member or reviewer), as well as familiarity with basic legal, institutional policy, and operational issues associated with human subject research regulations and state laws a plus. Ability to effectively advise and counsel senior leaders on matters of general research compliance and ethical human participant research practices. Demonstrated ability to plan and manage organizational growth and to use creativity in managing through transition and across disciplines, departments, and institutions in a fast-paced environment. Ability to work productively in a decentralized and highly-matrixed organization and be a positive contributor.
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: 49674BR
About Harvard University Medical School
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.