Regulatory Analyst

University of Miami•Coral Gables, FL

About The Position

The Disclosure & Scholarly Activities Management (DSAM) team has an exciting job opportunity for a Regulatory Analyst to work at the University of Miami. CORE JOB SUMMARY The Disclosure & Scholarly Activities Management (DSAM) Regulatory Analyst assists the DSAM Director with the development, oversight, and monitoring of compliance programs within the designated area. The Regulatory Analyst provides strategic advice and recommendations as to the adjudication and mitigation of Conflicts of Interest (COI), facilitates adherence to policies, rules, and regulations, and that policies and procedures are continuously monitored and evaluated.

Requirements

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.

Nice To Haves

Previous regulatory analysis experience is preferred.
Any appropriate combination of relevant education, experience and/or certifications may be considered.

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.