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

910-***-****

ad1jv1@r.postjobfree.com

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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