Clinical Research Trial
Resume:
Christian J. Newton
Clinical Research Coordinator seeking to utilize educational and professional experience in a role within the Sponsor/Clinical Research Organization (CRO) arena. Experienced in clinical trial execution at the site level, regulatory maintenance/review, and proficient in multiple electronic clinical data systems.
FAYETTEVILLE, NC
********@*****.***
EXPERIENCE
M3 Wake Research, Clinical Research Coordinator — Fayetteville, NC July 2022 – PRESENT
M3 Wake Research, Acting Assistant Site Manager — Fayetteville, NC October 2023 – PRESENT
• Responsible for performance and compliance of assigned protocols, including updating study documentation, adverse event reporting, maintenance of clinical data systems, and coordination of research procedures in accordance with FDA, ICH/GCP guidelines, Wake Research
& client Standard Operating Procedures.
• Recruits and evaluates potential patients for project participation, utilizing assessment tools and questionnaires to obtain trial required information to guarantee activation and ensure study enrollment milestones are being met.
• Supports oversight of clinical trial site submissions and regulatory approvals for assigned protocols.
• Cultivates strong working relationships amongst internal research staff and study team by proactively mitigating risks & ensuring potential barriers to success are resolved.
Key Accomplishment:
• Credited with tripling recruitment numbers & enrollment of first/only subject in United States on HAV study.
U.S. Army (NCARNG), Combat Medic Specialist — Winterville, NC June 2019 - PRESENT
• Provides emergency medical treatment in combat or training environments, as well as primary care, health protection, and evacuation from point of injury or illness.
• Responsible for the creation, oversight, and execution of long-term patient care plans in consultation with, or in absence of, readily available physicians or advanced medical providers.
U.S. Army (PAARNG), Healthcare Specialist— Annville, PA May 2018 - June 2019
• Performed daily clinical tasks such as patient visits, to include the recording of vitals, vaccine administration, performance of ECGs/EKGs, drug administration, allocation of laboratory samples, and phlebotomy. CLINICAL TRIAL EXPERIENCE
Clinical Trial for Adolescents with Major Depressive Disorders — Lead Study Coordinator
Performed as Lead Study Coordinator on an exploratory clinical trial, evaluating the efficacy of new investigational product to treat children and adolescents with major depressive disorders, with inadequate responses to SSRIs and psychotherapies.
SKILLS
Observation-based screening and
collection of patient information
Operation of medical/local
vendor equipment & instruments
iMedidata RAVE, Medrio, Clario, Calyx,
inForm/Oracle & Florence EDC Systems
Clinical Conductor, FIRECREST &
Longboat Clinical Systems
Phlebotomy/IV Therapy & Trauma Care
MS office, Clinical IT applications
EDUCATION
September 2019-May 2022
East Carolina University, Greenville,
NC
B.A., Political Science; Minor:
Russian Studies
December 2018 – May 2019
METC (Medical Education &
Training Campus), San Antonio, TX
NREMT Certification, Combat
Medic Specialist Military
Occupational Specialty (68W)
Awarded
CERTIFICATIONS/LICENSURE
EMT-Advanced (NCOEMS)
EMT-Basic (NREMT)
CLS/TCCC Instructor
BLS
GCP
IATA
C-SSRS
LANGUAGES
English (Native)
Esperanto (Fluent)
Spanish (Intermediate)
Russian (Proficient)
Clinical Trial for HAV — Lead Study Coordinator
Performed as Lead Study Coordinator on an observational sample collection clinical trial to support advancements in medical diagnoses of hepatitis diseases. Clinical Trial for Cytomegalovirus — Lead Study Coordinator Performed as Lead Study Coordinator on a phase-III observational clinical trial, evaluating the efficacy of new investigational product to treat symptoms of cytomegalovirus.
Clinical Trial for Pneumococcal — Lead Study Coordinator Performed as Lead Study Coordinator on a phase-III observational clinical trial, evaluating the efficacy of new investigational product to treat symptoms of pneumococcal disease in conjunction with seasonal influenza. Clinical Trial for COVID-19 — Lead Study Coordinator Performed as Lead Study Coordinator on a phase-III observational clinical trial, evaluating the efficacy of new investigational product to treat symptoms of COVID-19.
Clinical Trial for Influenza — Lead Study Coordinator Performed as Lead Study Coordinator on a phase-III observational clinical trial, evaluating the efficacy of new investigational product to treat symptoms of seasonal influenza.
Clinical Trial for Diabetic Peripheral Neuropathy — Lead Study Coordinator
Performed Lead Study Coordinator on a phase-II observational clinical trial, evaluating the efficacy of new investigational product to treat diabetic peripheral neuropathic pain.
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