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University of Miami · 1 month ago

Regulatory Analyst

Coral Gables, FL

Full-time

Hybrid

Entry Level

1+ years exp

The University of Miami is recognized as one of the nation’s premier research institutions and academic health systems. The Regulatory Analyst will assist the DSAM Director with the development, oversight, and monitoring of compliance programs, providing strategic advice regarding Conflicts of Interest and ensuring adherence to policies and regulations.

Higher Education

Responsibilities

Conducts reviews of protocol and other submissions and communicates with researchers as it relates to COI and University polices

Provides QA or QC functions

Assists with Project Management

Creates and adheres to metrics-driven timelines

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

Assists the Director in supporting the COI Committee including review of scientific protocols, setting meeting agendas, composing COI management plans, minutes, reports, and any additional necessary communications

Facilitates adherence to applicable Federal, state, and local regulations and University policies and procedures as requested by the Vice Provost for Research & Scholarship

Monitors new legislation or changes in regulations that might affect the University’s compliance in conducting scholarly activities (including research), recommending changes to administrative policies and procedures, as appropriate

Drafts appropriate individual and institutional COI management plans for COI Committee’s review, prepares, distributes, and tracks adherence to such plans

Coordinates responses to regulatory agencies and advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented

Interacts with appropriate persons/agencies (e.g., Human Subjects Research Office, Animal Care and Use Committee, Office of Technology Transfer, and General Counsel’s Office, etc.) to resolve compliance problems related to scholarly activities conducted at UM

Develops and presents educational programs for groups and individuals conducting scholarly activities at UM

Prepares DSAM’s scholarly activities compliance standard operating protocols related to federal regulations and university policies

Assists Director in the preparation of annual reports of DSAM and University related activities, summarizing efforts taken and changes to be implemented at both University and departmental levels

Assists Director in the creation and maintains web-based policy and procedures manuals intended to assist University community in maintaining compliance with scholarly activities standards and guidelines; updates as regulations change

Serves as the designee of the Director, as needed

Maintains DSAM related databases and audit files

Qualification

Regulatory analysisResearch ethicsMicrosoft OfficeProject managementInterpersonal relationshipsIndependent researchRecord keepingEffective communication

Required

Bachelor's Degree in scientific discipline required

Minimum 1 years of relevant experience

Ability 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

Ability to communicate effectively in both oral and written form

Ability to maintain effective interpersonal relationships

Commitment to the University's core values

Ability to work independently and/or in a collaborative environment

Proficiency in computer software (i.e. Microsoft Office)

Ability to accurately prepare and maintain records, files, reports, and correspondence