Associate Director of Regulatory Affairs Operations SMART IRB

Harvard University   •  

Boston, MA

Industry: Education, Government & Non-Profit


8 - 10 years

Posted 56 days ago

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 (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.

Basic Qualifications

B.S. or B.A., seven + years of administrative or project management experience preferably in an academic or health care setting.

Additional Qualifications

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