Jinky Harvey
Jacksonville,FL
Summary
Results-driven and devoted Clinical Research Coordinator with intensive training in clinical research of ICH GCP E6 (R2), FDA regulations, 21 CFR 11, 50, 54, 56, regulatory binders, protocols, and source documents. Significantly knowledgeable in clinical research and training that cover all aspects of protecting the rights, safety, and wellbeing of patients and collecting accurate, credible data according to ALCOA-C principles. Additionally, I am well versed in coordinating all aspects of clinical research studies. Moreover, experienced in coordinating research communication between study teams and staff. Proficient at maintaining housing essential documents including 1572, DOA, training logs, and investigator site file (ISF) documents. Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer two years' experience in the field and take on a fast-paced position.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Associate Clinical Research Coordinator
Mayo Clinic
Jacksonville, FL
09.2021 - Current
- Coordinate clinical trials from pre-study planning to post-study closure while maintaining regulatory compliance with FDA and ICH-GCP
- Recruited and screened potential study participants and coordinated and study visit with themguidelines
- Implement study protocols and ensure that all clinical trials and activities are conducted according to the study protocol, SOP's, and regulatory requirements
- Verify that all study participants are fully informed about the study procedures and sign the informed consent documents
- Collect and maintain accurate and complete records of all study activities in paper and in electronic data capture (EDC) system with attention to detail
- Compliance with FDA regulations and study protocols, as well as good clinical practice
- ,Monitor study activities, report adverse events, and ensure that the study subjects are receive the appropriate medical care
- Ensure adequate safety measures for the protection of the study subjects and ensure that the study procedures are performed according to the protocol requirements
- Assist with creating and maintaining accurate records of the trials documentation and report data to the sponsor in timely manner
- Collaborate with study team members, including investigators, and clinical staff, to ensure that the study objectives are met
Pharmacy Technician
Baptist Medical Center
Jacksonville, FL
08.2015 - 10.2021
- Maintained daily inventory of pharmaceuticals and ensured proper storage conditions.
- Prepared medications for dispensing by counting, pouring, labeling, and verifying doses.
- Performed data entry for patient profiles, billing information and prescription orders into the pharmacy software system.
Medical Internship
Our Lady of Fatima Hospital
Valenzuela, Philippines
09.2008 - 05.2011
- Assisted in patient history taking, physical examination and diagnosis under supervision of attending physician.
- Organized medical records and documents for review by the attending physician.
- Performed laboratory tests including drawing blood samples, analyzing results and recording them accurately.
- Administered vaccines to patients as prescribed by attending physician.
Mentor
Big Brothers Big Sisters Organization
Jacksonville, FL
08.2006 - 09.2008
- Helped children with homework, reading, and other schoolwork.
- Assisted children with daily activities such as dressing, eating and toileting
- Provide emotional support to young children
- Administered medication and treatments according to instruction from parents or doctors
- Developed age-appropriate educational activities for children
- Monitored and evaluated mentees' progress, providing feedback and guidance to ensure success.
- Mentored individuals on professional development topics such as communication skills, problem-solving and goal setting.
Volunteer at Nurse's Station
Shands Hospital
Jacksonville, Florida
09.2002 - 04.2005
- Answered patients; call signals, signal lights, bells, or intercom systems to determine patients' needs.
Education
Clinical Research Diploma, Clinical Research Fastrack -
01.2020
Pharmacy Technician Diploma Program, Everest University -
01.2015
Medical Education and Training, Our Lady of Fatima College School of Medicine -
01.2012
Bachelor of Science in Biology, University of North Florida -
01.2005
Skills
- Proficient in clinical regulations and guidelines such as ICH_GCP, FDA, HIPAA, and IRB requirements
- Excellent communication skills, both verbal and written
- Strong organizational and management skills
- Proficient in electronic data capture (EDC)
- Strong team work and collaboration: Ability to work independently and as a part of a team
- Attention to detail and great ability to accurately identifying errors or inconsistencies in documenting patient data
- Query Resolutions, being able to identify and address issues, critical thinking and propose appropriate solution
- Ethical conduct: adhere to the principles of integrity, confidentiality and transparency in all aspect of my work
- Proficient in computer skills, medical records, various software applications to manage the study data documents
- Excellent in time management skills: meeting deadlines, managing multi task, and prioritizing responsibilities
Languages
English
Full Professional
Tagalog
Full Professional
Spanish
Limited
Japanese
Professional
Mandarin
Limited
Certification
- Clinical Research Training, Clinical Research Fastrak - 2020
- Pharmacy Technician License, Everest University - 2015
Timeline
Associate Clinical Research Coordinator
Mayo Clinic
09.2021 - Current
Pharmacy Technician
Baptist Medical Center
08.2015 - 10.2021
Medical Internship
Our Lady of Fatima Hospital
09.2008 - 05.2011
Mentor
Big Brothers Big Sisters Organization
08.2006 - 09.2008
Volunteer at Nurse's Station
Shands Hospital
09.2002 - 04.2005