PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The IACUC/IBC/ESCRO Committees, Office of the Vice Provost for Research, has an exciting job opportunity for a Regulatory Analyst at the University of Miami, Medical Campus.
All activities that involve the use of live animals at the University of Miami must be reviewed and approved under public laws and regulations promulgated by the Animal Welfare Act, the United States Department of Agriculture, and the Public Health Service. The Institutional Animal Care and Use Committee (IACUC) perform this function. The Office of the Institutional Animal Care and Use Committee provides administrative support to the IACUC.
The University of Miami Institutional Biosafety Committee (IBC) is a University-wide committee responsible for reviewing and approving recombinant DNA research and biohazard projects. The committee sets containment levels in accordance with the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories 5th edition (BMBL) and other NIH/CDC guidelines. It also periodically reviews previously approved research projects for changes, which would necessitate increasing or decreasing the biosafety level and risk groups. The Office of the Institutional Biosafety Committee provides administrative support to the IACUC and ESCRO.
The Embryonic Stem Cell Research Oversight Committee provides ongoing oversight of research activities to ensure that faculty and staff comply with federal and state guidelines concerning the use of human embryonic stem cells (hESCs) and human somatic cell nuclear transfer (hSCNT).
CORE JOB SUMMARY
The Regulatory Analyst provides administrative and regulatory assistance to the IACUC/IBC/ESCRO Committees and is instrumental in supporting effective administration of these committees.
CORE JOB FUNCTIONS
Gathers and prepares documentation required to conduct all Post Approval Monitoring (PAM) processes.
Verifies protocols and addenda for the given Principal Investigator (PI), prepares protocol-specific PAM checklists, collects and reviews animal records and other pertinent documents, as needed.
Coordinates pre- and follow-up plans post-PAMs to include generating correspondence with PI and PAM team to clarify action items, gathers or requests information, schedules visits and follow-up meetings, and distributes pertinent documentation to PAM members and PIs.
Prepares documentation for regular quality control audits of animal protocols and site inspections to ensure compliance with the protocol and relevant standards, prepares reports of investigations/inquiries for internal and external use.
Provides administrative support in drafting, preparation, and presentation of educational programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance.
Maintains and updates data in compliance databases and tracks the progress of any actions mandated by the IACUC in regards to PAMs.
Tracks trainings requirements for investigators and research staff.
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies.
Attends meetings and provides support as needed in preparation for meetings.
Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
Provides support to investigators by reviewing submissions for content and ensures investigators are informed of the actions and findings of the IACUC/IBC/ESCRO.
Acts as liaison with DVR support staff to ensure animal ordering is accurate.
Verifies all animals are on approved protocols to ensure compliance with USDA and OLAW (NIH).
Assists with file reviews, follows-up on review process, and ensures protocols are closed accordingly with IACUC office standards.
Drafts correspondence that conveys IACUC/IBC/ESCRO deliberations and contingencies for approval of research activities.
Provides administrative and process related advice to individual faculty and staff in preparation of applications for research protocols involving live animal work, recombinant DNA and/or the use of human embryonic stem cells (hESCs) and human somatic cell nuclear transfer (hSCNT).
Maintains accurate records, databases, and generates letters.
Develops and maintains templates, creates files, and mails notices/annual renewals.
Adheres to University and unit-level policies and procedures and safeguards University assets.
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.
Bachelor’s Degree in relevant field.
Minimum 1 year working with animals and of regulatory research environment experience. Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
Knowledge of relevant federal, state, and local regulations.
Knowledgeable in the IACUC/IBC/ESCRO functions and guidelines required.
Knowledge of scientific and clinical research terminology.
Ability to maintain effective interpersonal relationships with the ability to deal professionally with all types of information, including that of confidential nature required.
Ability to communicate effectively in both oral and written form with investigators, IACUC/IBC/ESCRO members and their respective Chairs.
Skill in collecting, organizing, and analyzing data with strong attention to detail/accuracy.
Proficiency in Microsoft Office (i.e., Outlook, Word, Excel, and Access).
Courteous, service oriented, professional demeanor.
Ability to identify and set priorities, meet deadlines, and effectively perform a variety of tasks simultaneously.
To apply online, please visit our career site at miam.edu/careers, keyword search R100036845 or select the below link:
The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common purpose of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making UM a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 13,400 faculty and staff from all over the world.