Results-driven clinical research professional with expertise in trial management, regulatory compliance, and quality assurance. Proven ability to mentor teams and ensure adherence to ethical guidelines while optimizing research processes.
Overview
23
23
years of professional experience
Work History
Clinical Research Supervisor
Tampa General Hospital
Tampa
11.2022 - Current
Trained and mentored junior research staff on best practices in clinical research.
Monitored trial progress and addressed any issues impacting study timelines.
Ensured adherence to ethical guidelines throughout all phases of research projects.
Conducted quality assurance reviews of study sites to ensure adherence to Good Clinical Practices.
Ensured that all adverse events were reported promptly according to FDA regulations.
Reviewed data from clinical trials for accuracy and completeness.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Clinical Research Coordinator III
Tampa General Hospital
Tampa
07.2021 - 11.2022
Coordinated clinical trials to ensure compliance with regulatory standards.
Managed participant recruitment and maintained study documentation accuracy.
Scheduled and conducted participant visits for data collection and monitoring.
Trained new staff on clinical research processes and ethical guidelines.
Facilitated communication between participants, sponsors, and regulatory bodies.
Oversaw inventory management of study supplies and equipment usage.
Maintained confidentiality of sensitive patient information throughout research activities.
Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Clinical Research Coordinator
Skin Care Research
Hollywood
03.2021 - 06.2021
Coordinated participant recruitment and enrollment for clinical trials in dermatology.
Facilitated communication between study teams, participants, and sponsors to ensure clarity.
Managed documentation and compliance with regulatory requirements for study protocols.
Organized and maintained study files, including informed consent documents and reports.
Assisted in monitoring trial progress to ensure adherence to timelines and protocols.
Trained new staff on clinical trial procedures and best practices in research coordination.
Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Clinical Research Coordinator
Clinical Site Partners
Miami
11.2020 - 02.2021
Organized and maintained study files, including informed consent documents and reports.
Collected, processed and delivered specimens from trial participants.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
Conducted screening interviews to determine eligibility of possible subjects.
Took vital signs and collected medical histories as part of study protocols.
Educated participants on studies and anticipated outcomes.
Clinical Research Coordinator
Miami Veterans Affairs
Miami
06.2012 - 11.2020
Conducted routine visits to research sites to ensure compliance with protocol requirements.
Reviewed medical records for accuracy of source documentation prior to database lock.
Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
Monitored subject enrollment and tracked dropout details.
Conducted screening interviews to determine eligibility of possible subjects.
Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
Organized, analyzed and modeled study data.
Clinical Research Coordinator
Cleveland Clinic Florida
Weston
03.2008 - 11.2011
Reporting of AE's
Managed Investigational Drug supply Inventory & quality assurance
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Collected, processed and delivered specimens from trial participants.
Developed and maintained accurate and timely study databases.
Took vital signs and collected medical histories as part of study protocols.
Monitored subject enrollment and tracked dropout details.
Clinical Research Coordinator
Perimeter Institute for Clinical Research
Atlanta
08.2007 - 03.2008
Kept patient care protocols and clinical trial operations in compliance.
Conducted routine visits to research sites to ensure compliance with protocol requirements.
Reviewed medical records for accuracy of source documentation prior to database lock.
Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
Collected, processed and delivered specimens from trial participants.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Developed case report forms for data collection at investigational sites.
Clinical Research Coordinator
Allied Research Institute
Miami
02.2007 - 08.2007
Oversee the clinic along with four other Coordinators
Prepare Data Management of Phase 1 & Bioequivalence Clinical trials
Facilitated communication between study teams, participants, and sponsors to ensure clarity.
Trained new staff on clinical trial procedures and best practices in research coordination.
Collaborated with investigators to develop study materials and patient education resources.
Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
Clinical Research Coordinator
Sunrise Clinical Research, Inc
Hollywood
04.2004 - 02.2007
Assisted healthcare professionals with patient care and daily operations.
Scheduled appointments and coordinated with medical staff for efficient workflow.
Managed documentation and compliance with regulatory requirements for study protocols.
Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
Developed case report forms for data collection at investigational sites.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
Ensured proper storage of investigational product at investigator sites per GCP guidelines.
Laboratory Technician
Comprehensive Neuroscience
Fort Lauderdale
10.2002 - 03.2004
Conducted laboratory tests to support neuroscience research initiatives.
Operated and maintained laboratory equipment for accurate data collection.
Prepared samples and reagents for various experimental procedures.
Collected, labeled and stored lab samples according to laboratory specifications.
Prepared test samples and obtained and recorded test data in accordance with standards.
Completed lab tests and communicated results to supervising staff.
Education
Bachelor of Science - Health Services Administration
University of Phoenix
Tempe, AZ
03-2020
Medical Assistant
Concorde Career Institute
Miami, FL
06-1996
High School Diploma -
Miami Carol City Sr. High
Miami
06-1994
Skills
Clinical trial management
Regulatory compliance
Data analysis
Quality assurance
Team leadership
Resource allocation
Training and mentoring
Timeline
Clinical Research Supervisor
Tampa General Hospital
11.2022 - Current
Clinical Research Coordinator III
Tampa General Hospital
07.2021 - 11.2022
Clinical Research Coordinator
Skin Care Research
03.2021 - 06.2021
Clinical Research Coordinator
Clinical Site Partners
11.2020 - 02.2021
Clinical Research Coordinator
Miami Veterans Affairs
06.2012 - 11.2020
Clinical Research Coordinator
Cleveland Clinic Florida
03.2008 - 11.2011
Clinical Research Coordinator
Perimeter Institute for Clinical Research
08.2007 - 03.2008
Clinical Research Coordinator
Allied Research Institute
02.2007 - 08.2007
Clinical Research Coordinator
Sunrise Clinical Research, Inc
04.2004 - 02.2007
Laboratory Technician
Comprehensive Neuroscience
10.2002 - 03.2004
Bachelor of Science - Health Services Administration
Environmental Services Housekeeper at Tampa General Hospital, St. Joseph's HospitalEnvironmental Services Housekeeper at Tampa General Hospital, St. Joseph's Hospital