LiveCareer-Resume

patient eligibility resume example with 7+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Summary

Objective:

I am seeking to obtain a position as a Clinical Research Coordinator within your organization that will allow me to demonstrate and apply my skills that will benefit your company as a whole. With over 8 years of proven experience in clinical research and clinical trials.

Skills
  • Extensive experience in clinical research, with understanding of clinical trials methodology and clinical research regulations throughout knowledge of GCP and ICH guidelines.
  • Ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply my understanding of study protocols.
  • Experience in training all staff and implemented a training manual for reference.
  • Highly skilled and independent worker with attention to detail and the ability to keep track of multiple projects at the same time.
  • Strong computer skills, with high profienciency in EDC, CTMS, EDMS and MS-Office products such as Excel and Word.
  • Bilingual English and Spanish
Education
National Association of Healthcare Technicians Miami FL, Expected in Medical Assistant : - GPA :
Charles W Flanagan High School Pembroke Pines, FL, Expected in High School Diploma : - GPA :
Certifications
  • CCRC Certification
  • Medidata Rave Certified Research Coordinator
  • Phlebotomy License
  • Verified Clinical Trials and RSVP
  • IATA Certification/Transporting Dangerous Goods/ DOT
  • First Aid/CPR/BLS/ACLS/AED Certified
  • Health Science Core: OSHA/HIPPA/BBP/Hepatitis/Tuberculosis Standards/HIV/AIDS/Domestic Violence/Medical Errors certification
  • FL Laws and Rules for Nursing
  • GCP/ICH/CITI
  • HAZCOM Training/Bloodborne Pathogens/Biohazardous Waste
  • Otsuka's Good Clinical Practice Training, ICH E6 (R2) and Global Pharmacovigilance Safety Training
Work History
New Jersey Institute Of Technology - Patient Eligibility
Newark, NJ, 02/2019 - 07/2020
  • Responsible for ensuring subject eligibility for clinical studies, based on protocol criteria and within required time-frames.
  • Strictly review inclusion and exclusion criteria for all protocols
  • Verify subject medical records by ensuring that information corresponds to the study protocol
  • Update subject medical records in the electronic database
  • Complete edit checks and User Acceptance Testing as well as review eCRFs
  • Perform medical follow-up with subjects by phone or in writing (including clinically significant results and files put on hold)
  • Ensure that medical records are approved by physicians in order to determine subject eligibility
  • Perform quality control and follow-up for all documents
  • Help to prepare and review documents during regulatory agency visits.
  • Update reports following the acceptance of subjects on-study
  • Reviews data sets to clean data and issue data queries if needed
  • Assist in compiling information for their team's performance indicators
  • Team up with the project team, and ensure that data management services are delivered in a consistent, high quality manner
  • Perform inter-study transfers
  • Verify raw data by ensuring the consistency of the sequence of events.
  • Write letters and ensure they are transferred to subjects
  • Responsible for verifying and for controlling the quality and integrity of all generated study data to ensure compliance with procedures and internal and external regulations
  • Work with other medical/clinical team members on study documents including clinical trial protocol and amendments, ICF's, CRF's and study reports.
Icon - Senior Research Screening Team Lead
Mount Pleasant, SC, 06/2017 - 01/2019
  • Responsible for ensuring that clinical operations are being
    conducted smoothly by supervising employees, ensuring subject safety, verifying the facilities and supplies are available
  • Help, plan and organize their work unit's activities/operations according to his field of expertise, the work plan, and the needs of the division in order to achieve the expected results
  • Ensure that the required supplies are maintained satisfactorily; the correct quantities at the correct level of quality and in the correct location (inventory management)
  • Determine, as needed, the necessary actions in order to streamline efficiency
  • -Intervene and document when adverse behavior is displayed by subjects
  • Adhere to the timeframes required by the study, all while offering a quality customer service experience
  • Support employees in the fulfillment of their tasks
  • Train and ensure that employee skills are up-to-date and perform the related follow-up
  • Perform follow-up for employee absences on study (illness or other)
  • Follow-up with the clinical management with respect to disciplinary and performance management
InVentiv Health Clinical Research Services, LLC, - Research Assistant
City, STATE, 06/2015 - 05/2017
  • Intervene and document when adverse events occur and verify follow-up of adverse events on study, including following-up by phone
  • Perform catheter insertion and venipuncture
  • Prepare, collect and process pharmacokinetic and pharmacodynamic samples
  • Reviews data collected and inserts into the study database.
  • Measure vital signs within required time frames
  • Perform electrocardiograms
  • Measure physiological data (weight, height, bone structure)
  • Collect and process diagnostic samples (alcohol breath tests, urine samples)
  • Administer study medication
  • Perform intradermal, intracutaneous and intramuscular injections
  • Ensure that informed consent form is read; explain any study specific details and answer subject questions
  • Update files, check identification, search personal belongings
  • Intervene and document when adverse behavior is displayed by subjects
  • Distribute and monitor subject meals
  • Perform inventory and bagging of study samples
  • Prepare clinic for subject's arrival and clean up after subjects discharge plus any other duties assigned as training and experience allows
  • Inventory, document and ship biological samples
  • Review study documents after end of shift to ensure complete completeness and accuracy
  • Ensure compliance with GCP, GDP, and OSHA guidelines including Phase One Solutions SOP's, WI, and Policies
  • Participate in training sessions pertinent to job including classroom GDP/GCP training
Phase One Solutions - Clinical Research Coordinator Assistant
City, STATE, 06/2012 - 03/2015
  • Support the Clinical Operations teams with ongoing conduct of studies.
  • Assist in data management, regulatory paper works and other local administrative tasks as supervised by the clinical research coordinator
  • Perform diverse responsibilities requiring analysis, judgment and knowledge of specific study protocols.
  • Maintain accurate, confidential files and documentation of study participants., source documents for trials, maintain EDC and data bases.
  • Review of clinical study documents for recruitment
  • Complete all case report forms and distribute study medication and instructions to study participants, under the direction of the Investigator.
  • Assisting with the development of study documents, such as informed consent forms, submission documents, etc.
  • Screens, enrolls, and recruits research participants.
  • Performing source document verification as appropriate, with particular emphasis on proper collection of informed consent, adherence to regulatory requirements, and reporting of potential safety-related events
  • Responsible for verifyng the clinical unit set-up, enrollment assignment, baggage check and restricted items.
  • Maintaining ICF for updated versions
  • Verification of laboratory results, procedures forms and ensuring that all study activities start at the scheduled time

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Resume Overview

School Attended

  • National Association of Healthcare Technicians
  • Charles W Flanagan High School

Job Titles Held:

  • Patient Eligibility
  • Senior Research Screening Team Lead
  • Research Assistant
  • Clinical Research Coordinator Assistant

Degrees

  • Medical Assistant
  • High School Diploma

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