The IRB Generalist position plays an integral role in the day-to-day functions of the IRB office. Duties include preliminary evaluation of research studies for completeness and identifying other federal and institutional requirements for the project. The IRB Administrative Associate will be trained to support IRB meetings by preparing agendas, advising members on regulatory matters, writing meeting minutes, and providing post-meeting communications. The position will also process follow-on activities related to research studies.
Job Duties Outlined:
Perform review of submissions of research studies to determine applicable institutional and regulatory requirements.
Provide instruction and advice to researchers on regulations and research studies.
Attend IRB meetings, inform members about institutional and regulatory requirements, and write meeting minutes.
Communicate committee review results to the study team and field questions regarding the IRB’s conditions for study approval.
For research not requiring review by the convened IRB, determine readiness for non-committee review.
Process the electronic submission of all IRB submissions, including, but not limited to, amendments, problem reports, continuing reviews and study closures.
Assist research study teams in the use of the electronic submission system.
Keep abreast of changes in regulations and communicate changes to IRB members.
Other duties as assigned.
A bachelor’s degree; OR a combination of post-secondary education and/or work experience that equals 4 years.
Previous experience exercising independent judgment in a highly regulated environment which demands consistent accuracy and attention to detail.
Strong communication skills and the ability to interact professionally with faculty investigators, IRB members, and other compliance professionals.
Previous customer-service experience in a high-volume administrative office.