Experience

UNIVERSITY OF MIAMI DERMATOLOGY & CUTANEOUS SURGERY

• United States
• Medical Practices
• 1 - 100 Employee

• Sr. Regulatory Analyst

  • Jan 2020 - Present

  • Assist with writing of protocols, creating source documents, providing templates, writing Informed Consents and preparing and developing budgets for submission. • Implements research protocol and monitors participant adherence to protocol. • Prepares and submits studies to the Institutional Review Board (IRB). Maintains consent forms and sponsor correspondences. Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations. Submits annual reports. • Serves as liaison with pharmaceutical companies, clinical research organizations, and study monitors. • Meets with sponsors and PI's to review research case reports. • Assists investigators and their staff with required documents and documentation for clinical studies. • Responsible for the training of research clinical staff, residents, students, and faculty on research protocol procedures and informed consent development. • Oversees department implemented Standard Operating Procedures (SOP's) for procedures and documentation required for research. SOP's include training of personnel, consenting of research subjects, maintenance of records, confidentiality of medical records, study related documentation and reporting of protocol deviations/violations and adverse events. • Assist team to complete corrections/ queries required at audits/ monitor visits and takes action to correct deviations as needed. • Updates appropriate agencies regarding current status of research project. • Assists creating and managing with clinicaltrials.com records. • Maintains subject visit/ procedure log to assist with study invoicing. • Maintains department study status logs. • Assumes responsibility for new abstractor case reviews. • Works with QC team on the annual re-abstracting and case finding audit. • Participates in clearing edits required for submitting data to state data exchange partners. • Works with QC Team on any ad-hoc quality control studies. Show less



University of Miami Miller School of Medicine

• United States
• Higher Education
• 700 & Above Employee

• Regulatory Affairs Manager

  • Feb 2011 - Jan 2020

  • Coordinate the entire process of regulatory document submission to the IRB including communicating with ancillary committee, study team, business office and sponsors.• Review protocol package for completion after PRC approval has been granted to guarantee all required documents are included.• Compilation of documents in order to prepare the following forms for IRB submission to guarantee protocol compliance with federal regulations. This process will take place from initial approval throughout the completion of the study.• Communication with PI and study team in order to organize and prepare Investigator Initiated protocol amendments to the scientific committee (PRC) for approval previous to IRB submission. Assist PI in addressing communications from PRC requiring protocol amendments or other changes in the study.• Prior and after grant approval, maintain all study-related documents in both a virtual, shared location and in a physical study binder, both of which are updated and maintained throughout the life of the study.• Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Communicate with Clinical Coordinators and PI’s to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring.• Assist writing audit reports and follow-up on observation close-outs.• Advise researchers in study design, consent form creation and compliance with the IRB requirements.• Participate in University wide presentations, seminars and workshops on IRB requirements, federal regulations, and human research protections.• Communicate to Neurosurgery staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and amendments.• Communicate with the sponsor for completion and submission of regulatory documents via interlinks regular mail or email. Show less

• Human Resources Manager

  • May 2006 - Feb 2011

  1. Investigates performance and conduct problems thoroughly in a timely and confidential manner consistent with relevant policies and regulations up to and including final warning letters. 2. Make recommendations to PM Directors regarding performance and conduct issues consistent with policies and regulations. 3. Coordinate and support MSOM performance evaluation processes. 4. Explains and presents human resources policies, programs, services, and processes to all MSOM customers. 5. Work cross-functionally with other human resources managers and professionals to ensure human resource programs are delivered to meet MSOM needs. 6. Serve as human resources representative for DHRS, Kronos, Halogen and other IT systems. 7. Assist PM Directors in completing due diligence process regarding layoffs and re-organizations. 8. Assist MSOM managers and supervisors on the development of individual improvement plans in response to performance evaluations. 9. Responsible for managing all unemployment claims for MSOM including analysis, representation at hearings and follow up on required documentation. 10. Develops implements and publishes the HR Quarterly Newsletter. 11. Completes semiannual exit interview reports for review by leadership. 12. Participate in Performance Improvement Management series as a co-facilitator. Show less



Tropical Shipping

• Doral/Riviera Beach

• Human Resources Representative

  • Apr 2004 - May 2006

  Oversees recruitment and selection process for all positions, in accordance with the recruitment policy. Administers applicant testing, and maintains applicant tracking system. Provides counsel to management on application of policy, and resolving employee relations issues for the Miami offices, Puerto Rico and Dominican Republic. Serves as resource in providing advice to employees on any personnel related issue. Assist managers with workgroup training needs analysis and the development and delivery of training to meet business objectives. Show less



AECOM

• United States
• Civil Engineering
• 700 & Above Employee

• Human Resources Administrator

  • Sep 2000 - Apr 2004

  Responsible for directing all function necessary for the efficient operation of the Human Resources/Mentoring Program for Dade Aviation Consultants. Primary responsibilities include the following: 1. Administration of Federal and Local (State & County) regulations • Employment Law and Labor Relations including sexual harassment, EEO, ADA, FMLA. • Conduct investigations into complaints of harassment, or other alleged violations of employment law. • Provide counsel and training to management and staff on employee relations and compliance issues. • Coordinate the retention of appropriate records, reports and files for project-specific reference. • Ensure compliance with DAC contract requirements pertaining to employment and personnel including client approval process. 2. Wage and Benefit Administration • Coordination between Benefits Administration departments of various JV partners and project staff. Requires comprehensive understanding of various benefits programs. • Conduct salary surveys and provide management with information, which can be used as a basis for compensation agreements within the framework of project budget. • Track performance evaluation and merit review schedules to ensure timely processing. • Assist with new hire orientation. 3. Recruiting Relations • Coordinate recruiting efforts to meet project staffing needs. • Develop and recommend initiatives to management that will impact the project’s efforts to retain qualified existing personnel. • Coordinate activities of Outreach Programs. • Coordinate Mentoring Program associated with Students and Internships. • Manage interface with County in tracking staffing needs among all project contractors. 4. Employee Relations • Employee Communication • Coordinate communication of grievance procedures to staff and management. • Mediate and arbitrate conflicts between personnel (management and staff). Show less