The Office of the Vice Provost for Research, Office of Compliance Committees (IACUC/IBC/ESCRO) has an exciting opportunity for a Regulatory Analyst on the Medical Campus.
Job Summary (Purpose and Function):
Under the direction and guidance of the Director of Compliance, this individual provides senior level administrative and regulatory assistance to the IACUC,IBC, ESCRO Chair and Committees. The IACUC/IBC/ESCRO Regulatory Analyst is instrumental in supporting effective administration of these committees
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 the NIH/CDC guidelines related to recombinant DNA. It also periodically reviews previously approved research projects for changes, which would necessitate increasing or decreasing the biosafety level and risk groups.
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 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).
Accountabilities (For Non-exempt Employees Include Percent of Effort):
- Unit Administrator for overall function of the IBC to include the submission, review and approval processes of the IBC Committee:
- Acts as liaison between the investigators and the IBC reviewers to ensure confidentiality and efficient review process.
- Collaborates with Director, to develop knew processes, SOPs, and training materials.
- Attends IBC meetings and provide administrative support as needed and assisting in scheduling meetings, taking minutes which are reviewed by USDA inspectors, NIH and AAALAC site visitors, preparing agendas, and ensuring all materials have been appropriately distributed to committee vendors.
- Ensure investigators are informed of the actions and findings of the IBC:
- Provides support to investigators by reviewing submissions for content.
- Implements mandatory regulatory training for IBC researchers.
- Tracks training requirements for investigators and research staff.
- Sends timely response to written and phone messages requesting information.
- Sends timely decision correspondence to appropriate parties.
- Acts as backup support for Unit coordinators of the IACUC and ESCRO committees as needed.
- Coordinates the semi-annual inspection process, the semi-annual program review and reports to the Director of Compliance. Tracks all regulatory deficiencies and corrective measures and engages with dialogue with investigators, research teams, Environmental Health and Safety, Facilities and Division of Veterinary Resources (DVR) to resolve any pending matters.
- Facilitates any high risk, unclear or time-sensitive protocol process as well as acts as point of contact for any investigator experiencing a prolonged review.
- Restructures the existing semi-annual database to track vital regulatory items for accreditation bodies, federal regulatory agencies and for the post-approval monitoring process.
- Compiles animal census and other pertinent regulatory data; prepare drafts of annual reports to federal regulatory agencies.
- Conducts regulatory reviews prior to committee consideration to ensure submitted research is in compliance with submission requirements with state, Federal regulations and University policies:
- Oversees accurate and timely processing, tracking and filing of submissions to and actions by the IACUC/IBC/ESCRO, to include monthly notifications on submissions for federally mandated deadlines.
- Analyzes regulatory requirements, identify potential conflicts, and have thorough knowledge and ability to apply federal regulations and UM policies.
- Effectively communicates with investigators, IACUC/IBC/ESCRO members and their respective Chairs.
- Supports the Director in drafting, preparation, and presentation of educational programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance by University employees involved in IACUC/IBC/ESCRO research;
- Assists in the creation and maintenance of policies and procedures for the Regulatory Unit (e.g., SOPs) as well as prepare Power Point Presentation for their implementation and/or training materials.
- Attends IACUC/IBC/ESCRO meetings and provide administrative support as needed.
- Ensures investigators are informed of the actions and findings of the IACUC/IBC/ESCRO:
- Provides support to investigators by reviewing submissions for content;
- Tracks training requirements for investigators and research staff;
- Sends timely response to written and phone messages requesting information;
- Sends timely decision correspondence to appropriate parties.
- Maintains accurate files, both paper and electronic:
- Acst as liaison with DVR support staff to ensure animal ordering is accurate;
- Ensures all animals are on approved protocols to ensure compliance with USDA and OLAW (NIH).
- Assists with file review, follow-up on review process, and ensure 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 of IACUC/IBC/ESCRO actions:
- Administers and conduct quality assurance (QA) of the three on-line databases (e.g., InfoEd, Topaz, and C.I.T.I., etc.) tracking systems and shared drive files to maintain accuracy.
- Generates letters, develop and maintain templates, creating files, and mailing notices such as reminders of annual renewals to investigators.
- Performs other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.Minimum Qualifications:
- Bachelor’s Degree in a science related field required.
- Two years working in a regulatory research environment.
- Knowledge of scientific and clinical research terminology.
- Knowledgeable in the IACUC/IBC/ESCRO functions and guidelines required.
- Strong Microsoft Office applications skills, including Outlook, Word, Excel and Access.
- Strong skills with compliance related-software applications required.
- Excellent oral and written English communication skills (verbal and written) and interpersonal skills with the ability to deal professionally with all types of information, including that of confidential nature required;
- Ability to manage multiple tasks, work under pressure, and meet deadlines in a high workload environment.
- Courteous, service oriented, professional demeanor and excellent organizational skills with strong attention to detail/accuracy, with the ability to identify and set priorities and effectively perform a variety of tasks simultaneously.
- Any appropriate combination of relevant education, experience and/or certifications 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!]]>