Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic

Yaneysy Penate

Miami,USA

Summary

Comprehensive background in clinical research and patient liaison, with expertise in data management, clinical assessments, and supporting clinical staff. Excellent verbal and written communicator. Strong track record of supporting patients and colleagues. Bilingual (English, Spanish). Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in [Area]. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

University of Miami, Sylvester Comprehensive Cancer Center
06.2023 - Current
  • Assist Principal Investigator and Sr
  • Manager with assessing feasibility
  • Organizes and participates in study initiation visits (SIV) in collaboration with the study Team
  • Attends site disease group tumor board meetings and site disease group collaborative meetings
  • Works directly and communicates with SDG Leader and Sr
  • Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG
  • Participates in the orientation, mentoring, and coaching including Jr
  • Clinical Research Coordinator and Data Coordinator
  • Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary
  • Provide patient and staff education (in-services) regarding all Site Disease Group (SDG) specific protocols
  • Assist the PI in providing the patient and his/her family with a thorough description of the treatment and possible side effects related to study treatments
  • Review patient data with the PI to determine patient eligibility for protocol enrollment
  • Ensure all eligibility forms are completed and submitted for appropriate review
  • Assists PI in obtaining informed consent and document the informed consent process
  • Enter required information in Velos
  • Ensure study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents
  • Obtain relevant medical information from patient clinic charts/medical records
  • Maintain logs/progress reports to track both currently enrolled as well as follow-up participants
  • Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy
  • Participates in quarterly peer-review, quality control program
  • Determine data to be collected and develop forms for collecting/summarizing data
  • Work with the Data Coordinator to enter data onto case report forms and/or into computer database as appropriate
  • Complete corrections/queries required at audits/monitor visits
  • Ensure data integrity and consistency in computer database and written records
  • Execute the plan developed for procurement of protocol specific subject specimens, i.e
  • Pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed
  • Assists the Study Team that protocol lab kits, and study specific supplies are obtained as required
  • Ensure protocol specific data is entered into Velos
  • Take action to report and correct deviations or other problems
  • Verify accuracy of research data and monitor data quality control
  • Record serious adverse events, etc
  • In compliance with applicable regulations and report to IRB/Sponsor
  • Actively participates in monitoring visits/site audits, etc
  • Promptly reports side effects of treatment to the Investigator and ensures Regulatory is provided accurate information to report to IRB
  • In turn, ensures appropriate patient follow up is performed and follow up safety reports are completed and provided to Regulatory as required per HSRO policies, protocol specific requirements, GCP, and the federal regulations
  • Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs
  • Ensure that randomization and registration of patients entered onto Cancer Center sponsored clinical trials are performed in compliance with CRS and UM policies, the protocol, GCP, and the federal regulations
  • Establish/maintain contact with patients/participants, health care providers, community agencies, study sponsors
  • Update appropriate agencies (such as sponsors, regulatory, etc.) regarding current status of research projects
  • Ensures 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
  • Provide coverage for other CRS SDGs as needed
  • Engage in continuing education of research policies/guidelines
  • Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of latest trends in field of expertise
  • Other duties as assigned

Clinical Research Project Manager

University of Miami, Miller School of Medicine, Human Genetics Department
05.2021 - 06.2023
  • Advance knowledge of policies, procedures and regulations governing human research
  • Conducted research/clinical testing, & assured all protocols procedures were followed
  • Overseen/performed clinical assessments of study subjects including but not limited to screening, evaluation, & testing
  • Overseen and managed/entered data into various systems
  • Ordered/managed supplies/equipment processing, storage, inventory, & quality control for industry and NIH clinical research studies
  • Assisted in budget preparation/negotiation & managed trials finances
  • Assisted, prepared, & ensured grand applications, IRB/GCO submissions to internal and central IRBs
  • Coordinated study activities and human subjects’ enrollments
  • Assisted PI in the preparation of new protocol submissions, protocol amendments, & renewals of ongoing clinical trials from industry & NIH projects
  • Maintenance & management of regulatory master files for industry & investigator-initiated trials
  • Coordinated data collection, analysis and cleaning, performing regular audits to ensure that the data collected were complete and accurate, and that the research was being conducted as outlined in the protocol
  • Coordinated subject visits, tests and procedures with study partners, manage and facilitate visit schedules and workflows
  • Maintained oversight of subject charts, databases, and reimbursements
  • Ensured that overseen events and protocol deviations are reported to study team, sponsor, and Principal Investigator
  • Coordinated monitoring visits, provided follow-up to monitors and research team
  • Managed the collection of data from importable and exportable formats for rapid dissemination to Pis and sponsors
  • Developed appropriate baseline analyses and reports for the Pl, study funding agency and the IRB
  • Facilitated the preparation of conference abstracts, oral presentations, and poster presentations, and participated in the development of manuscripts for publication
  • Represented the study at internal and external academic meetings and community events
  • Act as a liaison to project partners to discuss new procedures that could be implemented
  • Worked with Principal Investigator (Pl) and study team to oversee the daily activities and needs of the clinical trials
  • Perform other research and office duties as identified and appropriate

Senior Clinical Research Coordinator

Albert Einstein College of Medicine, Department of Pediatrics’ Genetics
06.2021 - 12.2021
  • Leader in medical/biomedical research, patient care, Health Care Management, & Clinical Research Management
  • Advance knowledge of policies, procedures and regulations governing human research
  • Conducted research/clinical testing, & assured all protocols procedures are followed
  • Oversee/performed clinical assessments of study subjects including but not limited to screening, evaluation, & testing
  • Oversee and managed/entered data into various systems
  • Ordered/managed supplies/equipment processing, storage, inventory, & quality control for industry and NIH clinical research studies
  • Assisted in budget preparation/negotiation & manage trials finances
  • Assisted, prepared, & ensured grand applications, IRB/GCO submissions to internal and central IRBs
  • Coordinated study activities and human subjects’ enrollments between various sites
  • Assisted PI in the preparation of new protocol submissions, protocol amendments, & renewals of ongoing clinical trials from industry & NIH projects
  • Maintenance & management of regulatory master files for industry & investigator-initiated stroke trials
  • Coordinated data collection, analysis and cleaning, performing regular audits to ensure that the data collected are complete and accurate, and that the research is being conducted as outlined in the protocol
  • Coordinated subject visits, tests and procedures with study partners, manage and facilitate visit schedules and workflows
  • Maintained oversight of subject charts, databases, and reimbursements
  • Ensured that adverse events and protocol deviations are reported to study team and Principal Investigator
  • Coordinated monitoring visits, provide follow-up to monitors and research team
  • Managed the collection of data from importable and exportable formats for rapid dissemination to Pis and sponsors
  • Developed appropriate baseline analyses and reports for the Pl, study funding agency and the IRB
  • Facilitated the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication
  • Represented the study at internal and external academic meetings and community events
  • Act as a liaison to project partners to discuss new procedures that could be implemented
  • Worked with Principal Investigator (Pl) and study team to oversee the daily activities and needs of the clinical trials
  • Performed other research and office duties as identified and appropriate

Senior Clinical Research Coordinator

Icahn School of Medicine at Mount Sinai Hospital, Department of Neurology
11.2019 - 06.2021
  • Leader in medical/biomedical research, patient care, Health Care Management, Bi Clinical Research Management
  • Advance knowledge of policies, procedures and regulations governing human research
  • Conducted research/clinical testing, & assure all protocols procedures are followed
  • Oversee/performed clinical assessments of study subjects including but not limited to screening, evaluation, & testing
  • Oversee and managed/entered data into various systems
  • Order/manage supplies/equipment processing, storage, inventory, & quality control for industry and NIH clinical research studies
  • Assisted in budget preparation/negotiation & manage trials finances
  • Assisted, prepared, & ensure grand applications, IRB/GCO submissions to internal and central IRBs
  • Coordinated study activities and human subjects’ enrollments between various sites
  • Assist PI in the preparation of new protocol submissions, protocol amendments, & renewals of ongoing clinical trials from industry & NIH projects
  • Maintenance & management of regulatory master files for industry & investigator-initiated stroke trials
  • Proficient in preparation & processing new IRB research proposals, amendments, continuing review applications and adverse event reporting according to institutional and departmental policies/procedures and federal regulations & per protocols
  • Obtained inform consent under general supervision of PI and educate participants regarding study requirements
  • Remain available to subjects for all studies activities
  • Prepared reports for presentation in conferences and seminars
  • Mentored, train, & review the work of less experienced clinical research staffs
  • Developed workflow, internal procedures, prepare manuals/SOP & documents related to operation of the function
  • Served (primary CRC) as a liaison between sponsors, local IRB, Central IRBs, and internal department /staff
  • Interpreted complex clinical research data
  • Performed other research and office duties as identified and appropriate

Clinical Case Manager

University of Miami, Miller School of Medicine, Human Genetics Department
01.2018 - 11.2019
  • Assisted with short- & long-term follow-up for newborn screening cases
  • Coordination of patients' care plan as prescribed by genetics team
  • Provided patients support and resources to manage their care plans
  • Assisted with coverage of prescribed care plans from public and private payers
  • Coordinated clinical assessment for patients and research subjects
  • Managed the ordering of formula and medications for patients
  • Assisted in developing patient teaching materials and programs
  • Planned, implemented, and evaluated clinical research activities while maintaining good clinical practice
  • Performed complex research procedures, including patient assessment, specimen collection, data entry, interpretation, and evaluation of patient status and needs
  • Served as referral/point of contact to specialists
  • Coordinated patient identification, screening, recruitment, consent, enrollment, and follow-up for drug trials and registries such as Shire Genetics, Inc
  • Lysosomal and Gaucher, late infantile Metachromatic leukodystrophy
  • Maintained confidential files, regulatory documents and completed all case report forms in compliance with NIH, FDA, and HIPAA guidelines
  • Participated and facilitated all monitor visits and served as point of contact for sponsors & CRO
  • Assisted principal investigators with protocol reviews, IRB applications, annual reports, budget preparation, internal billing, and IRB submissions
  • Performed other research and office duties as identified and appropriate

Clinical Division Manager

Mount Sinai Icahn School of Medicine, Department of genetics & Genomic Sciences
06.2016 - 11.2017
  • Leader in medical and scientific training and education, biomedical research, patient care, and Health Care Management
  • Managed and monitored research clinical data input, collection, clarification, and enter data into various databases
  • Performed venipuncture, collected specimens, EKG procedures, and took vital signs
  • Coordinated clinical assessment for study subjects and obtained informed consent under PI minimal supervision
  • Liaised with patients regularly for interview, follow-up and patient care (including translation)
  • Maintained communication between programs, medical staff, and department heads by attending meetings and coordinating interdepartmental functioning
  • Planned, implemented and administered programs and services in the department, including coordination of care, clinic schedules, and assignments for staffs according to workload and space availability
  • Maintained awareness of advances in medicine, computerized diagnostic and treatment equipment, data processing technology, government regulations, health insurance changes, and financing options for treatment and testing
  • Prepared activity reports to inform management of the status and implementation plans of programs, services, and quality initiatives
  • Managed change in integrated health care delivery systems, such as work restructuring, technological innovations, and shifts in the focus of care
  • Consulted with medical, business, and community groups to discuss service problems, respond to patient's needs, enhance public relations, coordinate activities and plans, and promote health programs
  • Served as supervisor for assigned Clinical Operations staff within therapeutic area(s) and assessed assigned staff on work assignments, utilization and productivity
  • Provided expertise in managing programs and clinical monitoring activities utilizing advanced practices to assigned project teams
  • Provided support and guidance to team members for assessment and resolution to issues related to quality of care
  • Maintained staff's accountability to SOP, documentation, and productivity by promoting operational efficiency
  • Worked with internal and external training resources as required; ensure that all staff were current with their required training

Administrative Secretary

Mount Sinai Icahn School of Medicine, Department of genetics & Genomic Sciences
08.2005 - 06.2016
  • Managed and monitored data input, collection, clarification and legal requests, and entered data into various databases including IDX, Medgis, Lytec, Medical Manager, and Epic
  • Submitted insurance claims: consult, lab (genetic testing/molecular & cyto) to private payers, Medicaid, & Medicare
  • Performed venipuncture, collected specimens, EKG procedures, vital signs
  • Coordinated clinical assessment for study subjects and obtained informed consent under supervision
  • Liaised with patients regularly for interview, followed-up and patient care (including translation)
  • Managed office inventory and ordered supplies, replenishing stock as needed
  • Compiled and filed medical charts, reports and correspondence, ordered labs and procedures as needed to avoid delay and minimize interruption
  • Set up and managed systems for tracking research samples sent to laboratory for analysis
  • Directed daily operations of medical and administrative staff, ensuring adequate coverage
  • Carried out diverse administrative and data management duties including collation and maintenance of large datasets and liaison with other clinical centers, investigators and personnel
  • Served as primary contact for all protocol clarifications and logistical project-related issues
  • Maintained a rapid response rate at all times, in accordance with agreed standards

Medical Records Clerk - Student Health Clinic

Florida International University, Modesto A. Maidique Campus Student Health Centre
07.2002 - 12.2004
  • Provided administrative support to this busy practice, maintaining accurate records at all times
  • Handled storage, retrieval, filing, collection, delivery, archiving, preparation, indexing, scanning and quality assurance of health records for transfer into electronic document management system
  • Assisted with patient attendances /audit/ research and all other requests
  • Resolved merger of duplicate records physically and electronically and rehoused case-notes as needed to maintain full records and maintain availability of information
  • Acted as first point of contact for all case note and record requests from personnel
  • Always adhered to confidentiality requirements, reporting concerns promptly
  • Liaised regularly with billing, legal and other departments to request or distribute information
  • Maintained and audited filing sequence to ensure continued adherence to university SOP

Education

Bachelor of Science - Nursing

Sacred Heart
Puerto Rico
08.2023

Bachelor of Science - Health Care Administration

Kaplan University
01.2015

Skills

  • Proficient in Microsoft Office (all applications)
  • MediData
  • Oracle
  • Epic
  • InfoEd
  • OnCore CTMS
  • REDCap
  • WebDCU
  • TrialMasters
  • Lab applications Medgis & Covance
  • Adverse event reporting
  • Study protocols
  • Informed consent
  • Documentation Management
  • Electronic Data Capture
  • Patient recruitment
  • Investigational product management
  • Research SOPs understanding
  • Trial management
  • Phlebotomy
  • Subject Retention Strategies
  • Schedule Coordination
  • Relationship Building
  • Patient Care Coordination

Accomplishments

  • Achieved [Result] by completing [Task] with accuracy and efficiency.
  • Collaborated with team of [Number] in the development of [Project name].
  • Supervised team of [Number] staff members.

Certification

  • Client Confidentiality (HIPAA)
  • Certified Nurse Assistant (CNA) with Florida DOH License# CNA 363483
  • Certified Patient Care Technician (CPCT) with National License# GSY7P6Y8
  • CITI coursework/certification
  • CPR/BLS certification
  • Certification in Shipping and handling Dangerous Goods
  • MRS (Modified Ranking Scale) certification
  • NIHSS (National Institute of Health Stroke Scale International) certification
  • Cognitive assessments Certifications (MoCA, CERAO)
  • Health Disparities, Recruiting Acutely III Patients

Languages

Spanish
Native or Bilingual

Timeline

Clinical Research Coordinator

University of Miami, Sylvester Comprehensive Cancer Center
06.2023 - Current

Senior Clinical Research Coordinator

Albert Einstein College of Medicine, Department of Pediatrics’ Genetics
06.2021 - 12.2021

Clinical Research Project Manager

University of Miami, Miller School of Medicine, Human Genetics Department
05.2021 - 06.2023

Senior Clinical Research Coordinator

Icahn School of Medicine at Mount Sinai Hospital, Department of Neurology
11.2019 - 06.2021

Clinical Case Manager

University of Miami, Miller School of Medicine, Human Genetics Department
01.2018 - 11.2019

Clinical Division Manager

Mount Sinai Icahn School of Medicine, Department of genetics & Genomic Sciences
06.2016 - 11.2017

Administrative Secretary

Mount Sinai Icahn School of Medicine, Department of genetics & Genomic Sciences
08.2005 - 06.2016

Medical Records Clerk - Student Health Clinic

Florida International University, Modesto A. Maidique Campus Student Health Centre
07.2002 - 12.2004

Bachelor of Science - Health Care Administration

Kaplan University

Bachelor of Science - Nursing

Sacred Heart

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Yaneysy Penate