Regulatory Analyst

Regulatory Analyst page is loaded## Regulatory Analyst remote type:
Hybrid locations:
Coral Gables, FLtime type:
Full time posted on:
Posted Yesterday job requisition :
R
** 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, please review this .The Office of the Vice Provost for Research & Scholarship, 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.
** CORE JOB FUNCTIONS
*** 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.
** Department Specific Functions
*** 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.
*** 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 QUALIFICATIONS
***
* Education:

** Bachelor's Degree in scientific discipline required.
*
* Experience:

** Minimum 1 years…