Clinical Research Coordinator - David S. Hallegua MD, A Professional Corporation
(2023-05)
Rheumatology
- Review and monitor strict adherence to new protocol
- Creating source documents
- Maintain all research documents
- Scheduling of patients for research visits and procedures
- Screen patients using protocol inclusion/exclusion criteria
- Coordinate and assist physician in conducting patient visits
- Communicate effectively and courteously with study patients and sponsor
- Ensure that the drugs are correctly dispensed per protocol
- Collect and process blood, urine and other specimens
- Responsible for completion of study documentation forms, including case report forms and other study specific documents
- Verify accuracy of data collected, data entry and query resolution
Clinical Research Coordinator - Flow Health
(2022-09 - 2023-02)
Covid, Covid Flu and Saliva Direct
- Responsible for ensuring study is in compliance with local, federal laws and regulations
- Recruits, screens, consents potential study participants and outlines study objectives
- Maintains all documents related to the study, which includes collecting data obtained from research and administering questionnaires
- Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress and ensure they adhere to the study rules
- Racking samples, receiving, accessioning samples, reject samples and pipetting
- Manages the inventory of equipment and supplies and orders more as needed
- Attends meetings in order to promote the study
- Keeping track of all patient information for the study into the excel sheet
- Collecting research samples, labeling, storing and transporting all specimens to the freezer
- Collaborating with nurses and managers to make sure study runs smoothly
- Writing reports for the study
Clinical Research Associate/Data Lead - PAREXEL International
(2020-12 - 2022-06)
Neurology and Oncology
- Training staff with procedures
- Has detailed knowledge of the study protocols, lab manuals, and acceptable performance of quizzes.
- Enters study participants in the study participant tracking system, ClinBase, and study logs, maintain appointment calendars, and operates company information systems and computer programs.
- Conducts screening visits and study protocol specific participant visits, assists staff physicians in assessment of concomitant medications, adverse events, lab results and other test results.
- Performs appropriate psychometric and efficacy testing according to study protocol
- Receives authorized sign-off to verify accuracy of all study participant visits.
- Responsible for ensuring the following: sample collection (e.g., drawing blood samples or handling urine), processing, storage and shipment is according to protocol, lab manual or Sponsor provided documentation, following GCP and site SOPs to ensure accurate and complete data collection with documented Quality Control at each step.
- Prepares/monitors study supplies, stock levels, and equipment in clinic and lab
- Identify and problem solves study-related issues as they arise, bringing to the attention of the CRC, CLC, QM and management as applicable
- Ensure quality assurance and accuracy of source and CRF documentation in real-time and throughout the study. Performs corrections for QM, CRC, CLC and Monitor/Sponsor Representative in a timely manner.
- Maintains and updates knowledge of ICH GCP and SOPs to ensure compliance and proper application in work
Clinical Research Assistant - Veteran Affairs Hospital
(2018-02 - 2020-10)
Neurology, Podiatry, Vascular Research and Oncology
- Assisted with regulatory and IRB submission documents
- Performed vitals and EKGS
- Processing lab specimens to local and central labs
- Prepared for monitoring visits and audits
- Uploading documents into eISF (electronic investigator site file)
- Creating source documents and QA (quality assurance) patient charts
- Recruited study patients by calling subjects from database
- Obtains informed consent from subjects for research studies
- Updated temperature logs daily
- Attended SIV meetings
- Entered patient data in the EDC system and resolved queries
Clinical Research Assistant - Unison Clinical Medicine
(2016-09 - 2018-01)
Internal Medicine
- Data management for phase 1,2 and 3 internal medicine clinical trials
- Scheduled patient visits and study procedures
- Obtained vital signs and EKGs
- Entered patient data into the EDC system and resolved queries
- Performed filing, maintained regulatory binder and patient charts
- Prepared patient charts for review of gathered data
- Reviewed patient source documents for accuracy and completeness
- Recorded temperature of the thermometer in the logbook daily
- Packed/shipped biological specimen to the local and central lab
Clinical Research Coordinator Intern - Charles Drew/UCLA School of Medicine and Science
(2015-06 - 2016-08)
Endocrinology, Diabetes and Metabolism
- Screening potential patients for protocol eligibility and participating in the informed consent process
- Recruited study patients by calling subjects from database
- Ensured compliance with protocol and overall clinical objectives
- Entered data in the system and maintained study files
Receptionist Assistant/EKG Technician Intern - Encino Urgent Care Medical Clinic
(2012-11 - 2015-05)
Internal Medicine
- Observed MDs and the medical assistant team in ensuring optimal patient care and smooth daily functioning of office
- Assisted with patient medical histories and vital signs under supervision of the medical assistant
- Ensured the cleanliness, sanitation and maintenance of all facilities, exam rooms and equipment
- Obtained EKGs and forward print out to the doctor
Volunteer - Veteran Affairs Hospital
(2010-10 - 2012-08)
APECM research: Oncology, HIV and Diabetes study
- Assisted with EKGs and vital signs
- Answered calls, escorted patients to the ER
- Screening and scheduling subjects
- Collected data as required by the protocol
