The Human Subject Research Office (HSRO), Office of the Vice Provost for Research has an opportunity for an IRB Regulatory Analyst position on the Medical Campus.
The Human Subject Research Office (HSRO) provides administrative support for the Institutional Review Boards (IRB). The HSRO assists the IRB in its mission to protect human subjects who participate in research. This position will manage the privileged and confidential institutional review and approval process of all proposed research activities surrounding multi-site human subject research to protect their safety, rights and welfare.
The IRB Regulatory Analyst is instrumental in support of HSRO/Central IRB operations so as to meet its primary responsibility of protecting the rights and welfare of human subject research by:
Ensuring that submitted research is reviewed efficiently and is consistent with regulations by:
Having thorough knowledge of and ability to apply federal regulations.
Overseeing the accurate and timely processing, tracking and filing of submissions to and actions by the IRB.
Effectively communicating with investigators, sponsors, IRB Chair and IRB members.
Obtaining and distributing information required for convened IRB or expedited review, maintaining files and preparing and distributing minutes as per federal guidelines.
Maintaining accurate records of IRB actions by:
Recording meeting minutes in sufficient detail to document IRB deliberations.
Documenting communications with investigators, regulatory entities and any others involved in the conduct of submitted research.
Maintaining an accurate and comprehensive database of reviewed and approved research.
Maintaining records of expedited reviews, risk determinations, and any other activities that result in a review or action by IRB staff or members.
Maintaining, filing and archiving systems that allow access to open and closed studies.
Maintaining suspensions, administrative closures and final report submissions for the Boardbased pod.
Ensuring that investigators and sponsors are informed of the actions and findings of the IRB by:
- Issuing notifications of IRB actions to investigators and other appropriate entities.
Ensuring that initial and continuing review of research is conducted appropriately and in a timely manner by:
Making investigators aware of due dates for submission of renewal and other reports.
Ensuring that information submitted by investigators is adequate for effective review.
Advising investigators in the preparation of their applications and accompanying materials.
Conducting regulatory reviews for IRB review.
Serving as primary or secondary reviewer during IRB meetings when needed and appropriate.
Serving as IRB interface for subjects, investigators, sponsors and regulatory agencies by:
Answering questions and supplying information when requested, and conveying IRB actions to appropriate individuals.
Screening subject inquiries, resolving issues when possible and conveying results of interactions with subjects to investigators, sponsors and IRB members as directed.
Serving as the IRB liaison during audits by regulatory entities or sponsors.
Managing the activities of the IRB and overseeing the adequacy of IRB membership by:
Assisting the Chair in recruitment, training and continuing education of IRB members
Ensuring that the agenda is prepared and prioritized appropriately.
Ensuring that the materials necessary are provided during the meeting in order to conduct an effective review.
Ensuring that a quorum is present and maintained during convened meetings.
Responsible for conducting IRB meeting as required
Keeping members apprised of their responsibilities regarding conflicts of interest.
Assuming other duties as assigned. Job descriptions are not intended and should not be construed as an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job. Management reserves the right to revise duties as needed.
In order to fulfill the responsibilities of this position, you may be required to work nights and/ or weekends, or work may need to be performed outside of regularly scheduled business hours (i.e. attendance at IRB meetings, preparation for IRB meetings, work related to regulatory review etc.).
A Bachelor’s degree and 1 year experience required. Master’s degree is preferred. Previous IRB and regulatory analysis experience is required. IRB professional certification preferred but not required. This position requires a person who is knowledgeable in the IRB/HSRO functions, who is skilled in interpersonal relationships, oral and written communication, and who is able to deal with high volumes and rigid deadlines. Familiarity with research ethics and methodologies and ability to conduct independent literature research (including Internet-based research) are required. Computer literacy is a required skill. Any appropriate combination of relevant education and/or work experience may be considered.
The University of Miami is home to some of the brightest minds in the world. We are committed to educating and nurturing students, creating knowledge, and providing service to our community and beyond. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action Employer. Come join us!]]>