The Senior IRB Regulatory Analyst serves as the subject-matter expert when performing core job functions in the HSRO and is instrumental in support of IRB operations to ensure it meets its primary responsibility of protecting the rights and welfare of HSR by:
PROTOCOL REVIEW AND ANALYTICAL EVALUATION BY:
Using extensive knowledge of applicable law, regulations and polies governing human subjects compliance to conduct preliminary review and evaluation of HSR submissions requiring administrative review (exempt, not human research and not engaged), expedited review and full committee review;
Whether a project meets the definition of HSR, meets the requirements for one or more of the exemption categories or indicates the site under review is not engaged in human subject research; and
When a submission does not satisfy requirements for expedited review and preparing the submission for review by a fully convened meeting;
Conducting review under the Expedited process while:
Ensuring determinations are compliant with applicable federal regulations, state law, ethical principles and University policies; and
Ensuring documentation of determinations and notifications regarding determinations are compliant with applicable federal regulations, state law, ethical principles and University policies;
Ensuring that initial and continuing review of research is conducted appropriately and in a timely manner by
Making investigators aware of due dates for submissions of renewals and other reports; and
Overseeing the accurate and timely processing, tracking and filing of submissions to and actions by the
Communicating with researchers and research team members in a respectful manner that is understandable to individuals who may be familiar with the multifaceted review requirements of IRB review and with sensitivity to the impact that non-favorable determinations might have on the individual;
Providing expert consultation and guidance to the research community to produce submissions that are approvable; and
Supervising, coaching and mentoring IRB Regulatory Analysts and Specialist with their protocol review and evaluation.
SUPPORTING FULL COMMITTEE IRB REVIEW 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;
Conducting the meeting in compliance with applicable law, regulations and University of Miami policies;
Keeping members apprised of their responsibilities regarding conflicts of interest;
Serving as a Primary or Secondary Reviewer when applicable;
Preparing and distributing minutes as per federal regulations and guidance;
Ensuring that Committee members apply regulations, state law, official guidance and University of Miami policies during the review of submissions; and
Providing expert consultation and guidance to the Committee Members.
Supervising, coaching and mentoring IRB Regulatory Analysts and Specialist as they complete tasks to provide support to the full IRB Committee.
SERVING AS THE IRB INTERFACE FOR SUBJECTS, INVESTIGATORS, SPONSORS AND REGULATORY AGENCIES BY:
Providing expert consultation and guidance:
To IRB team members, Committee members and customers who contact the IRB with questions, issues or complaints;
When addressing subject inquiries and resolving subject complaints;
Providing expert consultation when conveying IRB determinations and the reasons for such determinations to investigators, sponsors, team members and IRB members.
ENSURING ACCURATE RECORDS OF IRB ACTIONS ARE MAINTAINED BY:
Confirming that meeting minutes are in sufficient detail to document IRB deliberation and are compliant with applicable requirements;
Documenting communications with investigators, research team members, subjects, regulatory entities and others involved in the conduct of submitted research in compliance with applicable requirements;
Ensuring an accurate, compliant and comprehensive database of research reviewed by the HSRO, including expedited review, full committee review, required determinations, suspensions and terminations; and determinations of serious or continuing non-compliance or unanticipated problems involving risks to subjects or others is maintained.
SUPRVISING, COACHING AND MENTORING IRB REGULAROTY ANALYSIS AND SPECIALISTS BY:
Training the analysts and specialists on each function described in the Core Job Functions of their position;
Coaching analysts and specialists so they acquire the skills needed to perform Core Job Functions effectively;
Setting performance goals and deadlines for tasks assigned to them;
Tracking progress on performance and providing constructive feedback as the team member works towards completion of a goal or task;
Addressing problems with work quality in an effective and timely manner;
Ensuring employees adhere to applicable law regulations and University policies;
Motivating team members and creating strategies to boost productivity.
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.
This list of duties and responsibilities is not intended to be all?inclusive and may be expanded to include other duties or responsibilities as necessary.
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.). This is expected in order to meet the requirements of this position.
Bachelor’s Degree in related field. Master’s degree
Certification & Licensing:
IRB professional certification preferred but not
One (1) year of relevant work
Previous IRB and regulatory analysis experience is
Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
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
Familiarity with research ethics and methodologies and ability to conduct independent literature research (including Internet-based research) are required.
Computer literacy is a required
Internal Number: R100031999
About University of Miami
The Human Subject Research Office (HSRO) provides administrative support for the Institutional Review Boards (IRB) and assists the IRB in its mission to protect human subjects who participate in research.
The Senior IRB Regulatory Analyst independently reviews and analyzes scientific and technical components of human subjects' research (HSR) protocols; ensures proposed research is reviewed at the correct level of review and in compliance with federal, state and University mandated laws, regulations, policies and procedures related to HSR protections. The Senior IRB Regulatory Analyst independently makes determinations required for research reviewed under the Expedited process; manages the privileged and confidential institutional review and approval process of all proposed HSR activities involving to protect their safety, rights and welfare.
The Senior IRB Regulatory Analyst provides analytical and administrative support to the IRB Committees by conducting review and analysis of every submission the Committee will review and applying regulations, state law, official guidance and University of Miami policies to determine gaps between the proposed research and applicable l...aw and SOPs; makes recommendations based on experience and knowledge and works with investigators, Committee Members and others to resolve issues identified during analysis in a time sensitive manner.
The Senior IRB Regulatory Analyst efficiently coordinates and manages IRB Committee meetings.
In addition, the Senior IRB Regulatory Analyst supervises, coaches and mentors IRB Regulatory Analysts and Specialists in the activities they conduct during pre-review and review of protocol and providing support for the full IRB Committees.