Sr. Regulatory Analyst (Hybrid)

University of Miami

  • Coral Gables, FL
  • Permanent
  • Full-time
  • 17 days ago
Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this .The Research Compliance Committees (ORCC) at the University of Miami is thrilled to announce an enticing job opportunity for a talented and driven Senior Regulatory Analyst.CORE JOB SUMMARYThe Senior Regulatory Analyst (SRA) works closely with and reports to the Director of Research Compliance to provide support to federally mandated institutional regulatory committees. Namely, the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC) and the Embryonic Stem Cell Research Oversight Committee (ESCRO) in the service of research excellence and compliance with legal requirements, and advice on best practices, including organizing and maintaining IACUC communication and records.The SRA provides UM researchers on best practices for performing research that is compliant with all relevant animal care and use and biosafety regulations and assists researchers in resolving barriers to compliance, including helping them develop protocols that are likely to obtain IACUC/IBC/ESCRO approval and guiding them through the approval process. In addition, SRA supports leadership of Office of Research Compliance Committees (ORCC) in all aspects of the ORCC office functions.CORE JOB FUNCTIONS
  • Conducts reviews of protocol and other submissions and communicates with researchers as it relates to regulatory deficiencies and University policies.
  • Provides QA or QC functions.
  • Assists with Project Management.
  • Creates and adheres to metrics-driven timelines.
  • Creates and presents research-related educational materials within and outside the University of Miami.
  • Prepares documents for submission to federal agencies.
  • Keeps abreast of current federal regulations and guidance documents, State laws, University of Miami policies and procedures as well as departmental SOPs and informs OVPRS leadership of changes.
  • Promotes quality improvement and best practice solutions.
  • Communicates with the research community, all OVPRS groups and external customers as applicable and provides consistent excellent customer service.
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.CORE QUALIFICATIONSEducation:Bachelor's degree in relevant field required with a background in Sciences or related field.Experience:Minimum 3 years of relevant work experience in a regulatory research environment a plus. Any appropriate combination of relevant education and/or work experience may be considered.Knowledge, Skills and Attitudes:
  • Knowledge of scientific and research terminology.
  • Proficiency in developing training/educational materials and guidance documents.
  • Ability to maintain effective interpersonal relationships.
  • Excellent verbal and written communication skills with the ability to deal professionally with all types of information, including that of a confidential nature, required.
  • Courteous, service oriented, professional demeanor and excellent organizational skills with strong attention to detail/accuracy and set priorities to effectively perform a variety of tasks simultaneously.
  • Ability to exercise sound judgment in making critical decisions.
  • Ability to maintain effective interpersonal relationships.
  • Ability to communicate effectively in both oral and written form.
  • Skill in collecting, organizing and analyzing data.
  • Proficiency in computer software (i.e., Microsoft Office).
  • Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
CORE JOB FUNCTIONS
  • Manages the protocol review process from pre-submission to approval which includes communication with animal users, veterinary services, IACUC reviewers and other relevant ancillary groups.
  • Guides investigators and research teams through the entire protocol life cycle, which requires the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues.
  • Works directly with ORCC leadership to assure compliance both for established and new animal users with applicable Federal and state regulations, and University policies and procedures.
  • Coordinates, participates, and administers all activities related to semi-annual facility inspections, laboratories, and other areas where animals are used for research to ensure compliance as per Federal, State and UM regulations and policies.
  • Advises ORCC leadership of deficiencies and tracks all necessary corrective actions, with follow up to ensure that needed actions have been implemented.
  • Assists ORCC leadership in preparation of annual regulatory reports and assessments.
  • Tracks pertinent program performance metrics. Works directly with ORCC leadership to examine opportunities for regulatory innovation and promote the use of novel approaches.
  • Acts as a mentor for new employees and finds ways to improve the department’s mentorship program.
  • Interacts with appropriate stakeholders (e.g. DVR, EHS, Facilities) to resolve research-related compliance problems.
  • Acts as a back-up for other senior regulatory analysts, as needed.
#LI-TR1The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click for additional information.Job Status: Full timeEmployee Type: StaffPay Grade: A9

University of Miami