Professional Experience
The Foundation for Sickle Cell Disease
Sr. Clinical Research Associate
September 2021 - Present
- Creation of source documents for each study and standard source log as required in research.
- Reviewed protocol requirements, ICF, and sources documents following IRB approval
- Interact with medical monitor at sponsor site, conduct all monitor visits and audits.
- Review the collection of data during the conduction of the study and report deviation from the protocol in a timely manner
- Collect signatures on the delegation log as per specific training and as assigned according to their qualifications
- Make sure studies follow the protocol, ICH, GCP, GLP, FDA regulations. Reviewed regulatory
- binders, reviewed training files, and made sure that quality was integrated into all the processes of the study
- Conduct study visits and interact with IVRS for dispensing medication.
- Ensured proper collection, processing, transfer, shipping of labs as per sponsor request, specimens, maintained OSHA standards.
- Interact with the IRB during initial submissions, continuing review and final close out reports for the studies.
- Enter data electronic, paper, and resolution of queries.
- Dispensed, retrieved, and returned investigational products, calculated subjects’ compliance, and maintained proper drug accountability log and subject records.
- Prepared and submitted VOC, Adverse Event, and Serious Adverse Event reports and conducted follow-ups with subjects. Report to pharmacovigilance SAE or as per sponsor instructions.
- Reported SAEs in a timely manner to client liaison and IRB, providing follow-up reports.
- Close Out the Studies with the sponsor, IRB and start the process of archiving documents.
Life Extension Clinical Research, Inc.
Clinical Research Manager
February 2016 - August 2021
- Managed clinical studies from initiation to close out.
- Contributed to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, revision of marketing materials, and any other clinical related documents.
- Prepared IRB submissions for approval, including original protocols and amendments, ICFs and marketing materials, interim and yearly review for ongoing studies,
- Reviewed protocol requirements, ICF and sources documents following IRB approval
- Prepared site initiation meetings with the staff.
- Assured completion of study starts up materials, CVs, Financial Disclosure Forms, professional licenses and essential documents.
- Trained site staff; documented on the Training Log.
- Collected signatures on the delegation log as per specific staff training and as assigned according to their qualification.
- Maintained regulatory binders.
- Reviewed the collection of data during the conduction of the study and reported deviations eof-to protocol in a timely manner.
- Conducted QA/QC of data and generated a QA statement report.
- Wrote and implemented CAPA2s if necessary.
- Created SOPs/ WIs and updated SOPs as needed.
- Ensured that the studies are were carried out according to study protocol, SOP2s, and ICH/GCP regulations and study-specific manuals and procedures.
- Performed various clinical trials activities such as Screening, ECG, Vital Signs, and several different subject questionnaires and scales.
- Assisted the Principal Investigator and conducted any procedures required per protocol.
- Received, dispensed, retrieved, and returned investigational products.
- Calculated subjects’ IP compliance and maintained proper drug accountability logs and subject records.
- Prepared and submitted Adverse Event and Serious Adverse Event reports and conducted follow up with subjects.
- Reported SAEs in a timely manner to client liaison and IRB, providing follow-up reports.
- Oversaw performance of in-house CRAs including co-monitoring to ensure compliance with study protocol and in accordance with scope of work.
- Identified areas of concern and escalated to Director or upper management as appropriate.
- Created source documents, eSource and paper CRF2s for many various studies.
- Developed and maintained a good working relationship with the investigator and study staff.
- Tracked and reported on study progress including site activation, patient enrollment, and monitoring visits.
- Reviewed key study quality metrics (e.g., eligibility, primary endpoints data, etc.) and determined appropriate action in conjunction with the study team.
- Planned and conducted staff training in GCP/GDP.
- Conducted biannual staff review process.
- Performed other duties as assigned.
Phase One Solutions Incorporated Miami, FL
Director of Quality Assurance (Clinical Trials)
October 2012 - September 2015
- Acted as the QA professional, responsible for setting high standards for data collection and management of clinical trials.
- Performed a variety of functions: internal and external audits, SOPs, management, monitoring data according to the protocol including consent, study and source documentation QC.
- Reviewed treatment in compliance with the protocol and staff training.
- Assured that Quality was maintained at every stage of the clinical trials (QbD).
- Ensured and managed compliance with the protocol, SOPs, GCP, ICH Guidelines and FDA Regulations.
Pharmax Research Miami, FL
Clinical Research Coordinator
August 2009 - September 2012
- Conducted studies assigned including Alzheimer’s and Osteoarthritis Trials (Phase III), and Flu Studies (Phase I)
- Assured proper informed consent process; built sources documents according to protocols, verified all sources documents generated for study conduct.
- Reviewed eligibility, screened via IVRS and proceeded with randomization to the end of the trial.
- Communicated with sponsor, kept phone log and correspondence, responded to site visit reports.
- Performed various clinical trials activities such as ECGS, Vital Signs and assisted the principal Investigators and conducted any procedure required per protocol.
- Dispensed, retrieved, and returned investigational products, calculated subjects’ compliance and maintained proper drug accountability log and subject records.
- Updated records for IRB continuing and final reports for a large number of Alzheimer studies.
- Prepared and submitted Adverse Event and Serious Adverse Event reports, conducted follow up with subjects.
- Participated in Sponsor and investigator-initiated studies for Pharmaceuticals.
- Assured regulatory compliance; communicated and submitted regulatory documents and reports.
- Reported SAEs in a timely manner to client liaison and IRB; provide follow-up reports.
- Responded to Data clarification Form inquiries in a timely manner
- Organized and maintained Regulatory Binders for review and archiving.
- Conducted Quality Assurance reviews of sources documents and data Ensured the accuracy, completeness, legibility, timeline of data reporting on case report forms which are derived from source documents.
- Planned and provided local and remote Quality Control and Quality Assurance functions.
- Provided complete, timely and accurate Case Report Form (CRF’s) completion
- Prepared for study audits: Sponsor and IRB.
Omnicomm Systems, Inc (Trial Master eCRF)
Quality Assurance Analyst
October 2008 - April 2009
- Performed QA trials.
- October 2008 – April 2009
- Built testing for electronic data capture software for clinical trial(s).
- Managed several QA testing and assurance plans for multiple projects (Phase I studies and Cardiology Phase II and Phase III.
- Assisted in the identification and resolution of program, system and subsystem deficiencies associated with QA trial test.
- Tracked timelines and defects for all client deliverables
Mount Sinai Medical Center (Cancer Center)
Clinical Trial Coordinator/Data manager
April 2007 - October 2008
- Served as Research Assistant Coordinator and Data Manager for oncology trials in breast cancer, lung cancer, melanoma.
- Ensured proper collection, processing, shipping of labs, specimens, maintained OSHA standards.
- Updated records for IRB continuing and final reports for a large numbers of oncology studies.
- Prepared and submitted Adverse Event and Serious Adverse Event reports.
- Collected, verified and entered electronic and manual data.
- Participated in investigators meeting for Sponsor studies and Cooperative group (National Cancer
- Institute, CLGB, RTOG, GOG) and Pharmaceuticals Companies.
- Assured regulatory compliance, communicated and submitted regulatory documents and reports.
- Reported SAEs in a timely manner to client liaison and IRB, provided follow-up reports.
- Submitted IND reports to the IRB in a timely manner.
- Responded to Data Clarification Form inquiries in timely manners.
- Organized and maintained regulatory binders for review and archiving
- Conducted quality assurance reviews of sources documents and data
- Planned and provided local and remote Quality Control and Quality Assurance functions.
- Assured proper informed consent process; verified all source documents.
- Communicated with the sponsor, kept phone logs and correspondence, and responded to site visit reports.
- Maintained enrollment logs, tracked and reported subject recruitment and retention.
SFBC International
Data Manager III
September 1998 - July 2006
- Coordinated many Phase I Studies, including trials with escalation dose.
- Scheduled and coordinated clinical trials from pre-study visit to closeout visit in the utmost
- responsible organized and effective manner.
- Conducted extensive communication with Sponsor, CROs and other vendors.
- Conducted Phase I studies with escalation dose.
- Received, dispensed, retrieved & returned investigational products, calculated subject compliance and completed proper drug accountability log(s) and subject records
- Insured proper collection, processing and shipping of lab specimens, maintained OSHA standards
- Collected, documented, and recorded AE/SAE’s
- Monitored study participants during conduct of the trial
- Conducted Q/C of source documents, patient consents, and CRFs prior to Sponsor Visits.
- Obtained all necessary study related supplies and equipment.
- Prepared all PK supplies for multiple crossover periods and backup samples prior to study start.
- Performed various activities such as ECGs, glucose finger sticks, vital signs, 24 hours urine collection, Holter monitoring, breath alcohol, pregnancy testing.
Education
- Bachelor of Science in Humanities
- University of Mayor de San Simon – 1980 – Bolivia
- Miami Dade Community College
- Selected courses
- Master Class Management – 2016
Certifications
- HIPAA and FIPA Seminar – 2015
- FDA Clinical Trials Seminar -2014
- Certification of OSHA regulations – 2014
- Certification collection drug testing – 2013
- Certification CITI Good Clinical Practice – 2007 – 2023
- CITI- Program – Biomedical -2019
- OHRP Office for Human Research Protections -2019
- Certification of Pharmacy Technician (Barry University) 2007
- Certification IATA -2008-2025
- ASCLS P.A.C.E. Transporting Dangerous Goods Training – 2008 – 2025
- American Registry of Medical Assistants – 2007 – Present
- Certification of Good Clinical Practices 2005 – 2026
- Certification of OSHA regulations – 2005
- Certification of Clinical Trials – 2002
Other Skills
- Therapeutic Experience
- Hematology, Sickle Cell Disease
- Circulatory Hypertension, QTC studies
- Hematology, Brest, Lung, non-small cell lung cancer, Multiple Melanoma, Sickle Cell Disease
- Alzheimer trials – Phase III
- Osteoarthritis – Phase I, Phase III
- Others: Early phase (phase I), Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics
- (PK)/ Pharmacodynamics (PD).
- Nutraceuticals combine with pharmaceuticals
- Professional Affiliation
- Member of the Association of Clinical Research Professionals since 2007-Present
- Member Society of Quality Assurance
- Computer experience
- Microsoft Word, Excel, Power Point (Trial Master, Oracle, Inform, Medidata, Medrio, AIMS
- Realtime CTMS/eSource), ERT (Almac, Suvoda) EMR (Practice fusion, eClinicalWorks).