To obtain a position where I may utilize my experience and contribute towards the success and growth of an organization.
Overview
45
45
years of professional experience
Work History
Customer Service Representative
RevGenetics, LLC
Miami, FL
12.2019 - 05.2026
Respond promptly to customer queries via email, phone or live chat.
Handle customer complaints, troubleshoot problems and provide appropriate solutions or alternatives.
Assist with taking orders, processing payments tracking shipments, and managing returns or exchanges.
Update and maintain accurate customer records and interactions.
Refer complex or high priority issues to the appropriate department or supervisors.
Regulatory Affairs
Nicklaus Children’s Hospital
Miami, FL
04.2014 - 04.2019
Constant communication with Research Administration, Investigators and Coordinators regarding the initial, continuing and changes in submissions of WIRB documentation.
Acquires signatures for the submission of documentation to WIRB.
Follows-up with WIRB regarding documentation submitted.
Submit Initial Study Forms.
Complete, sign, scan and send to WIRB when completed file in appropriate binder or forward to Coordinator to file.
Submit Study Renewal Forms.
Complete, sign, scan and send to WIRB when completed file in appropriate binder or forward to Coordinator to file.
Submit study closure, complete, sign, scan and send to WIRB when task completed file or return document to Coordinator.
Submission of changes in research and other administrative submissions.
Completion of Continuing Review forms for studies that are housed in Regulatory Affairs.
Attend meetings such as Research Staff, Regulatory Affairs, Lean, etc.
Maintains the CITI Training Certification database for the Research Institute.
Maintains the CVs and Medical Licenses folders in H Drive.
Inputs necessary regulatory fields in Study Manager/Reveal per study.
Maintains the Regulatory Affairs timeline database.
Maintains the Exempt study listing and closes Exempt studies as needed once publication has been obtained.
Prepares, maintains, and updates standard policies and procedures pertaining to Regulatory Affairs.
Update and maintain electronic exempt files.
Clinical Research Coordinator
Miami Children's Hospital
Miami, FL
07.2009 - 04.2014
Coordinates clinical research studies on human subjects; subject recruitment; follow-up; data management; detailed record keeping and regulatory compliance; report writing; correspondence with investigators, IRBs, and regulatory authorities; some participation in protocol writing, initial and continuing education for Good Clinical Practice compliance.
Reports to the Director of Miami Children’s Hospital Research Institute.
Utilizes Good Clinical Practices in the conduct of clinical trials.
Follow all Standard Operating Procedures for clinical research, and assist in the continuous improvement of those procedures.
Comply with the Hospital’s Research Finance Compliance policies and procedures.
Attend and participate in investigator meetings, pre-study visits, and initiation meetings, coordinator meetings as appropriate.
Communicate with the Sponsor or their representatives, and schedule and facilitate study Monitor visits, and facilitate communication between Principal Investigator and Sponsor or Sponsor’s representatives.
Communicate study objectives and procedures to all relevant hospital units involved with the study.
Interacts with patients and families to recruit study subjects and ensure compliance with the protocol.
Administrative Assistant
Miami Children's Hospital
Miami, FL
04.2003 - 06.2009
Responsible for the maintenance of all Human Resources employee records, reminders to employees of PPD and Safety class requirements and reminders to management team of employee competencies and evaluations that are due.
Responsible for RI’s Kronos by tracking all department employees scheduled and unscheduled absences; maintaining the department head/manager aware of CRC/ORA employee’s whereabouts; alerting Director/Manager when employees exceed the allowed number of unscheduled absences, exceed their allowable paid time off, require overtime pay, or deviate from planned employee time schedules.
Responsible for the Visiting Scientist by completing the proper forms and obtaining required documentation, Preparing the proper shadow record for TM&E and notifying security department accordingly.
Responsible for IACUC records, setting up the board members meeting and assisting the members accordingly.
Serves as back-up to the administrative assistant with phone and calendar coverage to screen department’s telephone calls and takes detailed messages when necessary.
Assists Research Staff with pre-approval travel forms and reimbursement forms, setting up appointments or with any questions or concerns on a daily basis.
Schedule travel arrangements as needed.
Serves as back-up to the Research Tech Assistant with supply orders and keys for employees.
Serves as back-up for secretarial responsibilities for the Chief of Research and the management team. This includes the updates for policies and procedures and all other clerical functions as needed.
Assists the Clinical Research Center with ORA emails, maintaining investigator’s records in the H: Drive, CITI Certification Records, etc.
Assists Manager of Clinical Research Projects with presentations at orientation and special events (reserve conference rooms, order meals and set-up arrangements).
Responsible for picking up the mail, to have it stamped/dated and distributed accordingly.
Assists with patient contact regarding Research matters as needed.
Administrative Assistant
John Alden Life Insurance
Miami, FL
10.1992 - 03.2003
Published mainframe reports via Adobe Acrobat through the company’s email server.
Utilized modification code written in SAS (Statistical Analysis System) and fine-tune queries to minimize CPU utilization.
Assisted in executing test plans for general projects.
Response for the data management process, validation of data loads and troubleshooting of batch cycle problems.
Troubleshooting and provided timely resolution to production problems, issues and concerns from Help Desk callers and system users.
Maintained security requests that come through the Help Desk email system.
Served as liaison between business Fortis and the business area to resolve system problems.
Coded ad-hoc reports in QMF.
Client Service Representative
Smithkline Laboratories
Miami, FL
01.1981 - 01.1992
Maintained client records, data entry and client contact.
Updated microfilm records in a timely manner.
Provided lab results to doctor’s offices.
Assisted doctor’s office in providing specimen and test results.