Sr. Regulatory Specialist

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The department of Psychiatry has an exciting opportunity for a full-time Sr. Regulatory Specialist to work onsite on the UHealth campus. The Sr. Regulatory Specialist performs functions necessary to assure institutional compliance with all applicable regulations, and standards of regulatory and accrediting agencies. The incumbent ensures that all regulatory license applications for University sites and laboratories are maintained current and submitted within the required due dates. This employee monitors the Corrective and Preventative Action Program. The Senior Regulatory Specialist supports the investigation and documentation of associated complaint, deviation, and non-conformance reports. Moreover, an employee in this position supports all aspects of the internal and external auditing processes.

CORE JOB FUNCTIONS

• Maintains knowledge of appropriate regulatory, statutory, and accreditation requirements, and
• Assists in all aspects of the Quality Assurance Program.
• Maintains knowledge of all quality assurance procedures, with a specific focus on those related to regulatory requirements, licenses, complaints, CAPA, deviations, and adverse event reporting.
• Assists in the annual review of standard operating procedures and policies.
• Reviews change controls for regulatory impact, including review of associated documents.
• Assists in the regulatory review of compliance programs associated with complaint handling and adverse event reporting.
• Manages metrics associated with job requirements to track and trend progress.
• Oversees regulatory compliance of internal quality assurance operations.
• Assists in review of complaints, CAPA deviations, and adverse event reports.
• Ensures that root cause(s) has/have been identified and that appropriate corrective and preventive actions have been taken.
• Assists in conducting internal and external audits, including the review of audit-associated documentation and report preparation.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

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.

Department Specific Functions

• The Department of Psychiatry has a growing portfolio of chart reviews, observations studies, and clinical trials. The incumbent will serve as the contract person across multiple projects providing regulatory support, drafting, and submitting required reporting for multiple agencies.
• Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
• Prepare and maintain regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.
• Communicate with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• Provide high level of technical and regulatory expertise and guidance to research faculty and staff in accordance with the current Food and Drug Administration (FDA) regulations/guidance and University of Miami policy.
• Develop training documentation and materials for Investigators and research employees.
• Ensures Investigators, Resident, Fellows and employees are properly trained on controls within the function and on University policy and procedures as well as tracking and maintaining records of those trainings.
• Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.
• Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit. Conduct periodic quality assurance checks across multiple projects and provide feedback to the study team.
• Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.
• Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request.

CORE QUALIFICATIONS

• Bachelor's Degree in relevant field
• Minimum 3 years of relevant experience

Knowledge, Skills and Attitudes:

• 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.

Any appropriate combination of relevant education, experience and/or certifications may be considered.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The 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 here for additional information.

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