Ivette Labrada
Clinical Research Data Specialist at Sylvester Comprehensive Cancer Center- Claim this Profile
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Bio
Credentials
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Outlook 2021 Essential Training (Office 2021/LTSC)
LinkedInAug, 2022- Oct, 2024 -
Balancing Work and Life as a Work-from-Home Parent
LinkedInJun, 2022- Oct, 2024 -
Being an Effective Team Member
LinkedInJun, 2022- Oct, 2024 -
Business Etiquette: Phone, Email, and Text
LinkedInJun, 2022- Oct, 2024 -
Time Management Fundamentals (2016)
LinkedInJun, 2022- Oct, 2024 -
Time Management: Working from Home
LinkedInJun, 2022- Oct, 2024 -
CITI Health Information Privacy and Security (HIPS) for Clinicians
CITI ProgramMay, 2022- Oct, 2024 -
Research and Data Protection (UM)
CITI ProgramMay, 2022- Oct, 2024 -
COVID-19: Insights for Higher Ed Leaders
CITI ProgramOct, 2021- Oct, 2024 -
Mental Health for Higher Ed and Healthcare
CITI ProgramOct, 2021- Oct, 2024 -
Participating in Vaccine Reasearch
CITI ProgramOct, 2021- Oct, 2024 -
Conflict of Interest
CITI ProgramJun, 2022- Oct, 2024 -
Conflicts of Interest
CITI ProgramMay, 2022- Oct, 2024 -
Clinical Research Protocol Compliance - SCCC Research Staff
CITI ProgramJun, 2022- Oct, 2024 -
Good Clinical Practice and ICH (GCP)
CITI ProgramJun, 2022- Oct, 2024 -
Group 1: Biomedical Researchers
CITI ProgramJun, 2022- Oct, 2024 -
Regulatory Administration of Reportable New Information - SCCC Research Staff
CITI ProgramJun, 2022- Oct, 2024 -
Biomedical Research - Basic/Refresher
CITI ProgramNov, 2020- Oct, 2024 -
GCP for Clinical Investigations of Devices
CITI Program, A Division of BRANYNov, 2020- Oct, 2024 -
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
CITI Program, A Division of BRANYMay, 2020- Oct, 2024
Experience
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Sylvester Comprehensive Cancer Center
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United States
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Hospitals and Health Care
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300 - 400 Employee
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Clinical Research Data Specialist
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Jun 2022 - Present
● Extract clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study. ● Manage workload of studies commensurate to level of experience ● Answer data clarifications (i.e. data queries) for each study. ● Schedule and meet with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. ● Assure clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. ● Assure all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. ● Maintain logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs. ● Participate in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required. ● Assists multidisciplinary team in research activities. ● Maintain study binders and filings according to protocol requirements and department policy. ● Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation, and other sponsor and/or protocol specific logs. ● Ensure work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
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Mount Sinai Medical Center of Florida
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United States
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Hospitals and Health Care
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700 & Above Employee
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Lead Clinical Research Coordinator
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Jan 2021 - Jun 2022
● Oversee subject recruitment and study enrollment goals of multipleOncology Clinical Trials for various disease sites.● Provide leadership and support to clinical staff to ensure all clinical trials meetits intended goals and are conducted in compliance with state and federalregulations.● Formally supervise, train and/or mentor new and current staffmembers.● Assist with the preparation of staff performance evaluations; provideleadership in identifying and implementing corrective actions/processes.● Track patient and study specific milestones, identifying standard of careversus study procedures, to properly invoice sponsors according to studycontract.● Plan, coordinate and manage activities associated with the initiationand completion of clinical trials.● Review screening patient charts to assure all assessments are complete andlab results are within range prior to approval of patient study enrollment.● Review and Audit shadow charts and data in Electronic Data CaptureSystems.
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Clinical Research Coordinator
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Aug 2018 - Jan 2021
● Review chart/investigational study participant eligibility withprincipal investigator; provide study information, education andparticipation requirements to both patient and family; follow properinformed consent process.● Coordinate patient scheduling for completion of protocol relatedresearch procedures; screening, enrollment, treatment and follow-upcare and study assessments.● Provide accurate and timely data collection, documentation, entry of completeelectronic and paper data capture case report forms; data maintenance andmanagement in study databases.● Assist in observing and informing principal investigator of adverseevents, including those reported by study participants.● Address adverse events and serious adverse events per protocol, advocatingfor study participants and quality standards throughout the lifespan of thestudy.● Identify, report, and help problem solve protocol deviations andunanticipated occurrences.
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Research Assistant
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Nov 2017 - Aug 2018
● Prospective Case Collection (PCC) multi-center, multi-arm, clinicalcase collection program to acquire breast image data and establish animage library of exams for use in future research studies, training,marketing, and advance new product development.● Perform daily review of breast center schedule for recruitment of potentialstudy subjects; arrange and schedule annual screening mammogram, studybreast image data acquisition and follow-up breast ultrasound.● Educated patients regarding all facets of clinical study participation; follow proper informed consent process; completed study requiredquestionnaires and assessments before and after study breast imageacquisition.● Prepare and maintain Institutional Review Board and regulatorypaperwork/study binder, to comply with institutional regulatory requirements.● Identify and report issues that may affect accuracy and quality of studydesign and implementation to meet study aims.● Maintain inventory of supplies and equipment; perform systemcleaning, maintenance, and calibration to ensure system is fullyfunctional for image acquisition.● Abstract and collect data from Electronic Medical Records, and studysubjects; complete accurate and timely entry of electronic case report forms;data maintenance and management in electronic database.
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Certified Medical Assistant
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Sep 2013 - Nov 2017
● Departments:○ Cardiology○ Colorectal Surgery○ Endocrinology○ Gastroenterology○ Internal Medicine○ Interventional Radiology○ Memory Disorder○ Neurosurgery○ Oncology○ Pain Management○ Surgical Oncology○ Urology● Conduct preliminary evaluations: weight measurement, temperature,blood pressure, pulse, oxygen level, pain assessment, review ofmedications, medical and surgical history: complete and precise chartdocumentation.● Enhance patient outcomes by providing educational materials onprocedures, medications and/or diets; clarify physicians' orders, andanswer all questions thoroughly; contacting patients to review lab andimaging results.● Prepare and administer medications to alleviate patientsymptom(s).● Prepare patients and room for various procedures: pap smear,biopsy, cystoscopy, catheter insertion and removal, suture/stapleremoval and dressing changes.● Sanitize, restock, and organize exam rooms and medical equipment;maintain inventory of medical supplies in sufficient stock by monitoringlevels and submitting replenishment orders before depletion.● Update/maintain inventory, expiration, and destruction logs forinjectable medications, vaccines, sample medications, hazardousmaterials for current and accurate tracking documentation.● Oriented and trained inexperienced staff on proper procedures andpolicies at multiple satellite locations; assisted with routine checks anddiagnostic testing by collecting and processing specimens.● Supported duties for diagnostic and technical treatment procedures, such as setting up and operating special medical equipment and apparatus.● Performed clerical duties: word processing, data entry, answeringphones, filing, request, fax, and scan pt medical records, appointmentscheduling, patient check-in and check check-out, insuranceverification, completing patient referrals for specialists.
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Education
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2006 - 2009
Miami Dade College
Associate of Science - AS, Nursing Science
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