Objective

Professionally experienced Clinical Research Technician for thirteen years, has earned master’s degree in public health, bachelor’s degree in health science, graduate in medical assistant, and a registered midwife. Enthusiastically, seeking to leverage my professional expertise to enhance my career development and seek a new inspiring role of a clinical or scientific research job in a reputable company or any desired position.

Experiences

Microbiology/Quality Assistant (Flex, Buffalo grove, IL.) October 2022- Present

Performs routine endotoxin testing and data analysis.

Performs routine Cleanroom environmental monitoring, viable, surface, air and CDA testing weekly

Performs incoming lab media qualification, PH meter, testing and reading

Collect, review and analyze test results to support irradiation process.

Performs review of test data with application of GDP

Participate in customer or regulatory audit

Crossed-trained in sterilization/dosimetry process

Performs data entry using STARLIMS.

Sample Operations Specialist, (AbbVie Inc., San Francisco, CA.) 09/13/2021 - 02/18/22

Handles sample shipments including reagents, receipt, storage, and transfer of biological samples in support of clinical and preclinical trials. Ensures end- to- end chain of custody including sample storing to laboratory freezers.

Responsible for study setup in the bioanalytical research Watson LIMS software based on defined timelines and standards

Ensures the correct storage and tracking od the biological samples in Watson LIMS

Maintains knowledge of current regulations related to the sample handling and ensures that reconciliation is achieved to deliver assay-ready samples to testing teams.

Ensure collection, delivery, analysis, and disposition of biological samples under the highest standards of quality, ethics, compliance, and in accordance with informed consent.

Interacts closely with bioanalytical scientists, Laboratory Sample Operations Group, Clinical Sample Operations, and project team leads and/or therapeutic area liaisons regarding sample chain of custody.

Perform QC reviews of laboratory testing data and laboratory notebooks to ensure compliance with relevant guidelines and SOPs.

Responsible for contracting labeling, storage, and disposition of critical reagents.

Clinical Research Technician 1, (AbbVie Inc., Grayslake IL) 10/2007 – 09/13/2021

Managed assigned duties efficiently and on time. Duties include Specimen collection including RNA and DNA storing, process assays, blood, and urine serum and plasma, instrument & laboratory equipment process, obtain vital signs, collect ECG records, patient biometrics, and competently record all data, and laboratory testing in human research development of crucial drug products. Effectively trained and work in a cross-functional team environment in shipping human specimen for sample analysis of biological material and dry ice air shipment according to 49 CFR 172 Subpart H Dangerous Good Transportation

Provided review in the study Phase 1 and Phase 2 protocol level execution as approved by regulatory compliance before work application, ensure quality data collection & documentation is achieved, and work in a research study focus on advancing a public health approach to healthy people and patient safety

Primary responsible for reviewing, preparing, and setting up every assigned unit study to ensure successful execution of the protocol and to achieve a good quality result

Developing standardized procedures for time-adjustments, streamline the review, modify activity schedule, and assign people to their daily assignment for hands-on implementation for study-specific on scientific research or development that achieve project and area goals.

Delegated as the Building Captain of Emergency Force Control 2010-2018 and facilitated safety activities and training within the Research and Development pharmaceutical internal standards in coordination with Senior Environmental Health Specialist, and participated on cross-functional teams to meet the safety objectives and track progress in the quarterly laboratory inspection

Responsible in the review study set-up report, provide strong technical initiative, and generate time adjustments efficiently & able to handle complicated studies and integrate the knowledge into research and development programs

Act as a lead senior clinical research technician around expertise, facilitate training to new hire employees and enhance their quality of work

Carry out assistance to the physician and nurses as need is foresighted, oversight in support of the research pipeline, and adheres to all department company’s leadership expectations.

Participate in the revision of work instructions, business, and operating procedures, working with supervisors and managers, and teams within the organization to meet study business guidelines and objectives. Experience in validating records and assist clinical operation team in conducting the clinical trials in Phase 1 Unit.

Communicate compliance status, priority issues, and business impacts to key stakeholders. Demonstrate business ethics and integrity. Demonstrate strong organizational leadership, complete task with accuracy and timely manner.

Promote punctuality in completing all unit training and compliance with Good Clinical Practice, adhere to IRB principles, Clinical protocol compliance, and ICH regulatory guidelines to adhere to the company’s SOP and business processes

Very well trained in clinical laboratory processing and conduct laboratory/biological analysis and clinical testing procedure including biomarkers and in vitro assays, Light transmittance aggregometry, Biomarker PBMC Isolation, True-culture, BTK occupancy, basophil activation, PMA and bioanalysis pharmacokinetic processing, Immune Phenotyping, Biomarker Flow Cytometry Process, QC Laboratory inspections, and applying on scientific rationale. Use laboratory instruments and computer systems to record data.

Delegated and promptly assist in the investigational product verification and administration for drug development

Conduct incident investigations/deviations, identify root causes, and implement improvement/action plans to prevent similar incidents from occurring. Interpret design plans and provide recommendations for process improvements.

Ensure safety and protection of study participants through compliance with the study plan, SOP, ICH GCP guidelines & Principles, and applicable regulations, annually complete training with GXP Compliance and quality System, Data Integrity

Perform quality control review in the activity schedule, data review and electronic source documents, and expedite the subject’s discontinuation procedures as ordered by the Principal Investigator.

Secure confidential data and documents following the FDA standard of evidence.

Medical Assistant/Phlebotomist (Northwestern Healthcare, IL) 05/2006-06/2007

Administered shots/immunization to infant, children, and adults

Performed blood/specimen collection, ECG, vital signs, weights, and heights, and expedite laboratory orders

Roomed in patients and entered their demographics and performed nursing triage to patients to surveying patient needs, satisfaction to promote quality improvement

Scanned/filed charts to the system accurately; make referrals, as advised by health provider

Familiarized in PDR, ICD-9/CPT coding diagnosis

Assisted in Minor Surgery Procedures including sterilization/autoclaving medical and surgical instruments properly

Medical Assistant and Phlebotomist (Family Care Group, IL.) 08/2004-05/2006

• Administered shots/immunization to infant, children, and adults

• Performed blood/specimen collection, ECG, vital signs, weights, and heights, and expedite laboratory orders

• Roomed in patients and entered their demographics and nursing triage to patients

• Scanned/filed charts to the system accurately

• Familiarized in PDR, ICD-9/CPT coding diagnosis

• Sterilized/autoclaved medical instruments properly

Production Associate (Medline Industry, Waukegan IL) 2003-2004

• Skilled in extensive array of rules and regulations, procedures, and process variety of invoices, and GMP

• Production Technician and assembler sealer/Organize stocks and maintain inventory

• Observed sterile technique as per company’s policy while in production area

• Maintained up-to-date reporting schedules of all inventory activity reports

• Provided input and suggestions to supervisor as requested

• Observed company’s policy procedures /Abide by all company safety and hygiene regulations

Education

Purdue Global University, Indiana, Illinois/Master of Public Health 12/2018-06/2020

Graduation date: June 12, 2020

GPA: 3.9

Purdue Global University, Indiana, Illinois/Bachelor of Science in Health Science 07/2015-08/2018

Graduation date: August 14, 2018

GPA: 3.9 Dean and Principal Awardee; magna cum laude

Olympia College, Skokie, Illinois/Medical Assisting 2004-2006

Graduation date: September 2005

GPA: 4.0 High Honors Awardee

Operating System/Laboratory &Computer Literacy

Windows 2014-2018 (MS Word, Excel, Power point); EPIC System (Computer, Charting, Documentation, and Filing of patient records in the system); Laboratory Equipment (Electronic Pipet, Balance and Centrifuges, etc.); Smart Draw 2016, Spotfire download, PIMS Electronic Source, Watson LIMS, ADOBE and Electronic Signature

Licenses Certification

Philippine Regulation Commission Board of Midwifery; CPR Basic Life Support; Medical Assistant and Phlebotomy, Communication for Leadership Success; Situational Leadership; Consulting process for US & Puerto Rick HCPs/Customers; HazMat Function Specific-Biological material and Dry Ice Air Shipments, HIPAA Basics Training, Incident Trading: Avoiding Risky Behavior, Ways to Succeed at Goal Setting, Recognizing and Responding safety Information, Certificate of Bloodborne Pathogen Retraining, R&D lake County environmental Training, Code of Business Conduct Certification, PIMW (Potentially Infected Medical Waste)Training & Certification, Conflict of Interest certification, Front Desk Service, Crisis and Security Training, Emergency Control Force building Captain Certification, Environmental Training for laboratory Employees, Fire Extinguisher Training, Biosafety Training, Globally harmonized System & Hazardous Communication Training & Certification; lake County R&D Emergency Response Certification, Environmental Health and Safety Training & certification, Adverse Event and Product Complaint process certification, dangerous Goods-Exempt Human Specimen Shipments Certification, Certificate of Completion Bloodborne pathogens, Good Clinical practice Certification; Certificate of Completion Introduction to Environmental Health Microbiology and Communicable Disease Control, Antimicrobial Resistance (Part2) Certificate of Course Completion, HIV Basic Biology, Epidemiology & Prevention; Certificate of Course Completion in Tuberculosis Basics; Certificate of Course Completion in Malaria in Pregnancy; Certification of Completion Conflicts of Interest course from the Legal Compliance and Ethics Center; Certificate of Completion There Never was an Age of Reason: Vaccines, Vaccine Hesitancy, and Vaccine Decision Making; Certificate of Completion Immunization Strategies: Using the Evidence and What Works to Improve Practice; GPRD Training OP-AC-001 Shipping PK Collection Samples 2017; TRAIN Learning There Never Was An Age of Reason - Vaccines, Vaccine Hesitancy, and Vaccine Decision Making 2019; TRAIN Learning Immunization Strategies: Using the Evidence and What Works to Improve Practice 2019; Certificate of Completion Course from the Legal Compliance and Ethics Center Reacting to a Violent intruder; Certificate of Completion Course from the Legal Compliance and Ethics Center Reacting to a Consulting Oricess for US & Puerto Rico HCPsCustomers; Laboratory Environmental Health Safety training 04/13/2020; Environmental Training for Health Employees 5/28/2020;GxP refresher 2020; Emergency Control Force Building Captain an Floor Guidance Document 2020; Investigator Site Personnel ICH GCP Training Certificate 2020: Thoughtful Communication course from the Legal Compliance and Ethics Cenetr; Respiratory Protection-Discretionary Users GPRD Training 2020; GCP for Investigators and Trial Sites Based on ICH E6; Respiratory protection-Filtering Facepiece Respirator (Disposable Mask), 2020; RAPS (REGULATORY AFFAIRSPROFESSIONALS SOCIETY)

References:

Stacey Orzel, Director, ACPRU Operations

ad0ka7@r.postjobfree.com

Christopher Castineyra, Clinical Research Scientist

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Andreas Alfer, ACPRU Senior Clinical Research Nurse

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Rene Jordan, ACPRU Clinical Research Nurse

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Arturo Palma, ACPRU Technician Supervisor

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