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Clinical Research Coordinator II

Location:
Atlanta, GA
Posted:
September 14, 2023

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Resume:

Professional Summary:

Adaptable, detail-oriented, and passionate about clinical research. Bilingual, with diverse experiences in both research and healthcare settings. Reliable and experienced working both independently and as a team. Searching for a dynamic clinical research opportunity to continue to learn and grow. Experience:

02/2022-Current

Sr. Clinical Research Coordinator Velocity Clinical Research

Savannah, GA

●Oversees and implements each study’s protocol to ensure compliance with ICH/GCP and FDA guidelines of several clinical research studies addressing health concerns from viral diseases to chronic illnesses in over 50 studies.

●Conducts study procedures to include but not limited to screening, medical records review, SAE reports, subject visits, surveillance calls, monitoring visits, study start-up and study close-out.

●Maintains and simultaneously QC’s participants’ source files to ensure participant eligibility and safety during trials.

●Effectively manages the needs of trial sponsors, medical monitors, the company, and participants as well as manages investigator site files and maintains regulatory documents.

●Assists the finance team with invoices for procedures conducted for the 10 clinical trials I spearhead as well as contribute to budget adjustments, if needed for retention of participants.

●Coordinates with the data entry team by transcribing source and query resolution in EDC. Supports lab personnel with study supplies logistics and processing/shipping of biological samples.

●Manages a team of 47 members including A/CRCs, EDC, lab personnel, and staff with delegated tasks.

10/2021-02/2022

Assistant Clinical Research Coordinator Velocity Clinical Research

Savannah, GA

●Performed delegated tasks on several clinical research studies addressing a wide array of health topics including but not limited to viral diseases, infectious diseases, chronic illnesses, vaccines, metabolism, and endocrinology.

●Worked with a diverse range of participants to answer questions while conducting the informed consent process.

●Conducted screenings, follow-up visits, and safety surveillance with participants, which included collecting data and vitals, by performing phlebotomy, EKGs, and observing for adverse events post-receipt of the investigational product.

●Trained and re-educated over 1,000 participants on documenting symptoms and vitals using electronic and paper data collection diaries.

●Conducted safety surveillance calls and eDiary reviews by carefully documenting any pertinent details.

10/2019 – 08/2021

Eye and Tissue Recovery Technician ConnectLife

Syracuse, NY

●Collaborated to procure donor bone, nerve, tendons, corneas, veins, and research samples via aseptic technique by traveling to multiple hospitals in the Upstate New York region.

●Communicated relevant anatomy and tissue concerns for medical chart documentation.

●Performed gross decontamination and sterile preparation of the donor while maintaining donor integrity to obtain cultures from tissues procured. Performed appropriate and competent reconstruction of donor following tissue recovery.

●Independently reviewed donor medical history and lab work, for birth tissue eligibility. Performed the informed consent process including ample time for answering questions with donors. Coordinated with labor and delivery staff to set up sterile procurement tables in the operating room.

●Autoclaved instruments post-recovery. Packaged tissues for shipment to sponsors for further processing. Completed proper disposal of biohazard waste and performed weekly terminal cleans of the office OR.

03/2015 – 07/2019

Emergency Department Scribe Vituity

Los Banos, CA

●Assisted providers, nursing staff, and clerks with English-to-Spanish translation while documenting provider-patient interactions involving medical history, symptoms, physical examination, treatments, and procedures.

●Accurately documented vitals, laboratory results, radiological findings, EKGs, chart reviews, consultations, and medical decision-making on a real-time basis in the patient’s Electronic Medical Record.

●Performed floor training, supervision, and feedback for new-hire scribes.

07/2017 – 07/2018

Research Assistant CSU Fresno Neurobiology Department

Fresno, CA

●Studied and maintained mutant and wild-type strains of Drosophila Melanogaster for a research project at CSU Fresno focused on learning and memory deficits associated with the overexpression of the tau protein associated with Alzheimer’s Disease.

●Precisely performed genetic crossing strains for examination of the tau protein via Western Blots.

●Communicated with principal investigator and colleagues regarding study progress and processes improvement.

06/2015 – 01/2016

Chemical Technician E&J Gallo Winery

Modesto, CA

●Performed chemical and physical analysis of wines/spirits via FTIR, UV/Vis, Density Meter, Autotitrator, CO2/O2 Meter, Distillations, Cold Stability and Turbidity Meter.

●Assessed and prioritized sample analysis and expedited data results to meet wine production deadlines.

●Collected data via the LIMS management system and conferred with colleagues for data validation.

●Contributed to the research and development of suitable materials to maintain product stability.

●Trained new hires on equipment handling and troubleshooting while adhering to safety practices and quality system requirements of the Analytical Services Department.

Education:

Certifications:

May 2015

University of California Merced

Bachelor of Science in Chemistry

Minor in Cognitive Science

ICH/Good Clinical Practice

IATA Dangerous Goods Regulations

Basic Life Support - CPR/AED

Medical Scribe Professional

Skills:

Biliterate & Bilingual in English and Spanish. Proficient in Microsoft Office, & Programming in R language and

MATLAB

Platforms Proficiency:

●IRB: Center for IRB Intelligence (CIRBI), Alpha IRB

●Regulatory: Complion, Clinergize, VeevaVault, Advarra eRegulatory

●EDC: LIMS Management System, Inform, iMedidata, Zelta, Encapsia, ERT Global

●Electronic Health Record System: EPIC, MyChart, HealtheConnections

●eSource: IQVIA eConsent, Clinical Research IO (CRIO), Encapsia eDiary: Patient Cloud, StudyHub, Science 37, IBM Clinical Development

●Lab: Preclarus, Xcellerate Labcorp, Fetch

●IRT: ALMAC, FlexAdvantage, Endpoint, SBIR, Signant Health, Suvoda

●Training: Firecrest, DrugDev, Long Boat, GSK myLessons

●CTMS: Clinical Conductor

●Inventory: SLOPE

●Other: ePIP, Lifesphere



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