LEYDA VALENTIN
Miami,Florida
Summary
Dedicated In-House Clinical Research Associate experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer over 20 years' experience in the field and take on a fast-paced position. Highly effective and organized leader with excellent communication skills and extensive hands-on experience of all aspects of clinical trials from study start up to study completion.
Overview
26
26
years of professional experience
Work History
In-House CRA III
ICON PLC
Raleigh, NC
11.2022 - Current
- Supports Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
- Facilitate resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Provide support with the development of case report forms and other study related documents.
- Coordinate with clinical sites to ensure timely collection of data points throughout the course of a study.
- Communicate effectively with clinical staff regarding project timelines, expectations, protocol deviations and adverse events reporting procedures.
- Compile weekly/monthly progress reports achieved during the course of a trial.
- Draft agendas, minutes and other meeting materials throughout the course of the study.
- Track subject enrollment status, screening results and adverse events
- Provide support for all aspects of the clinical trial process including recruitment, data collection, and closeout activities.
- Monitor drug supplies at investigative sites to ensure adequate supply throughout the duration of the trial.
- Coordinate shipment of study materials between sponsors, investigators, vendors.
- Ensure timely completion of essential documents by investigators and research staff.
- Organize and track essential documents related to clinical trials according to ICH GCP guidelines.
- Responsible for uploading essential documents into Electrical Trial Master File (eTMF).
- Periodic review of the eTMF.
- Follow-up on outstanding site issues until resolved.
- Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Support study team in preparing for site audits.
- Attend and participate in Investigator Meetings.
- Attend site monitoring visits to perform site regulatory binder review and collection of documents.
- Check electronic data capturing systems for integrity and compliance, prior to on site monitoring visit.
- Maintain timelines and ensure accuracy and completeness of data entered into study systems.
Team Leader Clinical Research Coordinator & Phlebotomist
Cenexel/Research Centers of America, LLC (RCA)
Hollywood, Florida
09.2019 - 10.2022
- Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
- Trained new team members and acted as a mentor.
- Monitored clinical trial progress by attending team meetings, coordinating site visits, and reviewing source documentation for accuracy.
- Maintained timely communication with sponsors regarding project updates and issues that arose during the course of the study.
- Coordinated shipments of supplies needed for study sites.
- Provided guidance to research staff on protocol-specific operations procedures.
- Provided technical support to investigators regarding data entry into electronic case report forms.
- Collected and reviewed source documentation for accuracy of data entered into eCRFs.
- Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
- Maintained accurate records of study documents including eCRFs, informed consents, laboratory results.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Took vital signs and collected medical histories as part of study protocols.
- Monitored subject safety during trial period by collecting information on adverse events reported by subjects or healthcare professionals.
- Assisted in preparation of submissions for Institutional Review Board approval process.
- Maintained Investigator Site File.
- Performed drug dispensation and accountability.
Clinical Research Coordinator & Phlebotomist
Suncoast Research Group, LLC
Miami, Florida
03.2019 - 09.2019
- Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
- Trained new team members and acted as a mentor.
- Monitored clinical trial progress by attending team meetings, coordinating site visits, and reviewing source documentation for accuracy.
- Maintained timely communication with sponsors regarding project updates and issues that arose during the course of the study.
- Coordinated shipments of supplies needed for study sites.
- Provided guidance to research staff on protocol-specific operations procedures.
- Provided technical support to investigators regarding data entry into electronic case report forms.
- Collected and reviewed source documentation for accuracy of data entered into eCRFs.
- Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
- Maintained accurate records of study documents including eCRFs, informed consents, laboratory results.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Took vital signs and collected medical histories as part of study protocols.
- Monitored subject safety during trial period by collecting information on adverse events reported by subjects or healthcare professionals.
- Assisted in preparation of submissions for Institutional Review Board approval process.
- Maintained Investigator Site File.
- Performed drug dispensation and accountability.
Legal Assistant
REYES LAW FIRM
Hialeah, Florida
01.2018 - 03.2019
- Scheduling.
- Client Intake.
- Notary.
- Setting Client Claims with Vehicle Insurance Companies & Slip/Fall Claims.
- Requesting Police Reports.
- Entering information in Data Base.
- Assisted Attorney with client Recorded Statement and Examination under oath.
- Confirming client Independent Medical Examination appointments.
- Setting up client vehicle Inspection appointment with Insurance Companies to resolve property damage.
- Requesting Property Damage Photos and Estimates.
- Requesting Client’s Medical Records and Billing.
- Requesting Vehicle Policy Disclosures.
- Prepared Client Demand Package for Attorney.
- Confirming/Negotiate client’s outstanding balances with clinics and Hospital for treatments received.
Team Lead-Research Coordinator & Phlebotomist
QPS-MRA, LLC (Broward Research Office)
Hollywood, Florida
01.2013 - 10.2017
- Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
- Trained new team members and acted as a mentor.
- Monitored clinical trial progress by attending team meetings, coordinating site visits, and reviewing source documentation for accuracy.
- Maintained timely communication with sponsors regarding project updates and issues that arose during the course of the study.
- Coordinated shipments of supplies needed for study sites.
- Provided guidance to research staff on protocol-specific operations procedures.
- Provided technical support to investigators regarding data entry into electronic case report forms.
- Collected and reviewed source documentation for accuracy of data entered into eCRFs.
- Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
- Maintained accurate records of study documents including eCRFs, informed consents, laboratory results.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Took vital signs and collected medical histories as part of study protocols.
- Monitored subject safety during trial period by collecting information on adverse events reported by subjects or healthcare professionals.
- Assisted in preparation of submissions for Institutional Review Board approval process.
- Maintained Investigator Site File.
- Performed drug dispensation and accountability.
Clinical Research Coordinator, Recruitment Department & Phlebotomist
Miami Research Associates Inc / MRA Clinical Research
South Miami, Florida
04.2011 - 01.2013
- Perform clinical and study procedures as per study protocol and SOP’s
- Assist the Study coordinator during the conduct of the clinical trial
- Participate in training sessions.
- Phone Screening.
- Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
- Performed Vital Signs measurements and ECG
- Performed blood Draws, collection of urine samples and pregnancy tesst.
- Performed Breathalyzer and Drug screening.
- Review of subject and study documentation.
- Source Document collection
- Transporting clinical specimens to the laboratory.
- Supervision of the clinical subjects in the absence of the Clinical Study Manager.
- Cooperate with the Quality Assurance Unit during Audits and Audit Follow-up.
- Ensure compliance with appropriate MRA SOP’s, GCP and ICH guidelines.
- Executed other duties as may be required by the Director of Operations.
Senior Screening, Recruitment Coordinator & Phlebotomist
CETERO Research
Miami Gardens, Florida
01.2007 - 07.2009
- Coordinate with other departments in preparing study screening & recruitment documentation.
- Perform clinical and study procedures as per study protocol and SOP’s.
- Participate in training sessions.
- Appointments scheduling and confirmation.
- Filing and faxing paperwork.
- Answering phones.
- Administering consent.
- Providing an overview of the study to the subject.
- Collection of clinical diagnostic samples.
- Confirming demographic information
- Complete all protocol required screening tests.
- Responding to subject questions.
- Completion of required paperwork.
- Responsible for study subject admission activities.
- Assist with management of medical records.
- Performed vital signs, ECG, height and weight and calculation of BMI.
- Performed blood Draws, collection of urine samples and pregnancy test.
- Performed breathalyzer and drug screening.
- Helping create staff schedules.
- Ensured compliance with appropriate SOP’s, GCP ICH guidelines.
- Cooperate with and support QA and Regulatory Group during audit activities.
Senior Coordinator Assistant/ Phlebotomist
SFBC International Inc
Miami, Florida
11.1997 - 07.2006
- Perform clinical and study procedures as per study protocol and SOP’s.
- Performed study events and collect clinical data.
- Facilitate all communication between the clinical department.
- Perform patient care.
- Performed Vital Signs, ECG, Blood Draws, collection of urine samples, Finger Sticks.
- Breathalyzer, Drug screen.
- Height, Weight and calculation of BMI.
- Assist doctors and nursing staff in a routine examination and treatment.
- Blood Centrifugation.
- Prepare sample tubes for studies.
- Stock all medical supplies, Facilitate paperwork to pharmaceutical companies.
Education
Skills
- Good clinical practice
- Clinical Documentation
- Site Management
- Document Management
- Time Management
- Training and mentoring
- Adaptability
- Excellent Communication
- Relationship Building
- Reliability
- Teamwork and Collaboration
- Problem-solving
- Decision-Making
- Organizational Skills
- Knowledgeable in Clinical Systems
- Multitasking
- Data Collection
- Case report management
- Phlebotomy
- Trial oversight
- Developing Study Tools
- MS Office
Vendor System Experience
- EDC: Veeva Vault, Oracle Inform, Medidata Rave, Datalabs
- ETMF: Veeva Vault
- IVRS: Suvoda IRT, Bracket, Fisher Clinical Services, Clinphone IVRS
- Share Point
- OPRA (TRI): Risk Based Monitoring
- EDiaries and study questionnaires: Signant Health/Trail Manager
- Site portal for documents exchange and communication: Drug Dev
- Study Trainings: Investigator Space/Trifecta
- Cardiac Safety (ECG’s): ERT/Clario
- Central Labs: PPD Preclarus
Languages
- Fluent English and Spanish
- Strong verbal and written communication skills.
References
Available upon request.
Timeline
In-House CRA III
ICON PLC
11.2022 - Current
Team Leader Clinical Research Coordinator & Phlebotomist
Cenexel/Research Centers of America, LLC (RCA)
09.2019 - 10.2022
Clinical Research Coordinator & Phlebotomist
Suncoast Research Group, LLC
03.2019 - 09.2019
Legal Assistant
REYES LAW FIRM
01.2018 - 03.2019
Team Lead-Research Coordinator & Phlebotomist
QPS-MRA, LLC (Broward Research Office)
01.2013 - 10.2017
Clinical Research Coordinator, Recruitment Department & Phlebotomist
Miami Research Associates Inc / MRA Clinical Research
04.2011 - 01.2013
Senior Screening, Recruitment Coordinator & Phlebotomist
CETERO Research
01.2007 - 07.2009
Senior Coordinator Assistant/ Phlebotomist
SFBC International Inc
11.1997 - 07.2006