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Clinical Research Medical

Location:
Queens, NY
Posted:
November 23, 2020

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Resume:

Maia Tutberidze, MD

*** ******* ***, ********, ** 11238

757-***-****; adh2yt@r.postjobfree.com

https://www.linkedin.com/in/mmmmai

Green Card holder. Authorized to work in the US

Core Competencies:

Excellent interpersonal communicator with a scientific (medical science) background with

advanced problem solving and listening skills

Effective delivery of scientific presentations to both science literate and lay audiences

Keen ability to navigate ambiguity and cope with a rapidly changing environment

Ambitious, bold and persistent to difficult challenges with a strong passion to deliver the best results

Well organized, detail-oriented, highly adaptive, self-motivated, highly productive, efficient, hard-working, dedicated,

Result focused and competent in requisite software

Excellent work ethic and ability to work in a collaborative team environment as well as independently

Outstanding analytical skills. Ability and passion to do deep primary research

An Entrepreneur with an excellent project management ability and business acumen Objective: Long-term Career in a CRO or Biopharma

Background

European-Educated MD (Unlicensed in the US)

Associate Medical Professor

Medical Science Liaison (Contract) – MSL at ENMEDIC Clinic High Technology Diagnostic Laboratory and Endocrinology Center

More than three years of clinical rotations at medical school, including one-year Internship Focus: Oncology, Neurology, Women’s Health and Internal Medicine (Concentration: Endocrinology, GI - Gastroenterology)

Contract Pharmaceutical and Healthcare Sales Representative (GI – Gastrointestinal & Supplements)

Tutor; Health Educator, Entrepreneur, Pharmaceutical Market Researcher

Clinical Research Assistant; Clinical Study Sub-Investigator, An Alternate Member of IRB

General Knowledge of Clinical Development; Trials Design, ICH/GCP, FDA guidelines, Pharmacovigilance Education:

David Tvildiani Medical University, Tbilisi, Georgia

Medical Doctor (MD); (Language of instruction at the medical school – English; Six-year medical program based on UMSLEs – US Medical Licensing Exams and one-year pre-med) Courses & Certification (2013 – 2020)

Miami University (CITI) Course for Investigators and Clinical Research

Coordinators

Johns Hopkins University Design and Interpretation of Clinical Trials

Duke University Regulatory Affairs Training Program

Biopharma Institute ICH-Good Clinical Practice (ICH-GCP)

Duke University Medical Neuroscience

San Francisco University Diabetes, Diagnosis and Management

Johns Hopkins University Biology of Cancer

PharmaSchool Pharmacovigilance in Clinical Trials

MyCME Continuing Medical Education courses in Oncology and Gastroenterology

NIH Introduction to the Principles and Practice of Clinical Research

UC San Diego Drug Discovery, Development and Commercialization

University of Cape Town Understanding Clinical Research: Behind the Statistics

Imperial College London Study Designs in Epidemiology

University of Minnesota Healthcare Marketplace

University of Minnesota Medical Device and Pharmaceutical Innovations

Veritas Healthcare Solutions CRA and DSA/Pharmacovigilance training programs

ACMA Medical Affairs - Training Program

Membership: Member of IRB, AMWA, MSL Society

Languages: English - Fluent; Georgian – Native; Russian - Advanced Computer: Proficiency in Microsoft, PowerPoint, Word, and Excel Other: Open to travel (80%) and relocate

Professional Experience:

An Alternate Member of Institutional Review Board (IRB) 04/16 – Present Ochsner Clinic Foundation; New Orleans, LA

Participate in reviewing all research activities involving human participants and document its findings regarding ethical considerations, scientific merit, and adherence to federal regulations and IRB policies and procedures.

Evaluating patient safety and potential risk to human subjects.

Reviewing of clinical protocols & ICFs using GCP-ICH regulations for clinical studies with clinical investigators and other IRB members.

Health Safety Consultant 09/2018 – 03/2020

LLC GeoProduct Company - Rustavi, Georgia

Conducting safety and health training services that assist in regulatory compliance and promoting safety awareness/safe work practices. Review and evaluation of individual cases and health conditions. Consulting for disease prevention. Healthcare/Pharmaceutical Representative (1-year Contract) 06/2017 – 07/2018 ProPharma Sales LLC; Procter & Gamble; Territory: Brooklyn, NY, Queens, NY

Presenting Procter & Gamble’s OTC, GI(Gastrointestinal) medications to doctors (Gastroenterologists, Primary Care Physicians and/or other healthcare staff)

Driving outcomes through relationship building, education, and scientific presentations

Developed and maintained working relationships with KOLs

Managed and planned strategically within the territory

Identified opportunities resulting in streamlined operational processes and increased productivity Achievement: Received performance-based bonuses for achieving and exceeding objectives in each consecutive quarter. Visited about 17 medical offices a day and increased sales. Clinical Research Assistant

Ochsner Medical Center; New Orleans, LA 05/2016 – 08/2016

Clinical research data management

Assisting in auditing and regulatory process

Tutor in Physiology 02/2014 – 12/2015

Private Consulting, Maui, HI and Honolulu

Associate Medical/Adjunct Professor 02/2010 – 04/2013 Tbilisi Medical University ‘Hippocrates’- Tbilisi, Georgia (Republic) Founder and Director

LTD AutoTrader, Rustavi, Georgia (Republic) 03/2011 – 03/2013

Developed general business acumen and firm grasp of market dynamics

Developed and executed several marketing strategies that increased sales; Assisted in sales Medical Liaison and Physician Manager

ENMEDIC Clinic - High Technology Laboratory & Endocrinology Center, Tbilisi, Georgia 01/2008 – 01/2010

Managed and planned strategically within my territory

Presented & discussed laboratory services and scientific data to healthcare providers (Mostly Endocrinologists, as well as Cardiologists, Oncologists, Gynecologists and Primary Care Physicians)

Established and maintained collaborative relationships with doctors including KOLs

Identified opportunities to streamline operational processes resulting in increased productivity

Maintained databases for tracking professional society contacts and partnership activities

Identified and established new business contacts

Undertook relevant research, Reviewed and synthesized relevant literature. Assisted in marketing & sales activities as well and achieved objectives; Provided strategic input on the development of promotional and advertising materials. Pharmaceutical Liaison (Contract, Temporary)

MANA Pharmaceutical; Tbilisi, Georgia Republic 03/2007 – 09/2007 Clinical Study Sub-Investigator 02/2006 – 03/2007

Central Clinic; Rustavi, Georgia

Organizing and overseeing the daily activities

Review Investigators Brochure prior to performing study related activities

Ensure informed Consent has been obtained prior to performing any study procedures

Evaluating personal, assisting with recruitment, consenting, screening and enrolment of patients in clinical studies

Monitoring research participant to ensure adherence to study rules

Ensuring site compliance with study-specific laboratory procedures, and standards of Good Clinical Practice

(GCP)

Engaging with subjects and understanding their concerns; Employ financial acumen in budgeting and expenditure

Communicate medical results to patients, acting as a liaison between patients and health care professionals.

Evaluate and assesses laboratory reports; Document all findings in subject specific source documents

Provide ongoing assessments of study subjects including any potential Adverse Events or Serious Adverse Events and ensures proper reporting and documentation of such events

Provide coverage for Primary Investigator

Lecturer, Private Tutor & Health Educator

Tbilisi State Medical University and Pedagogical University; Tbilisi & Rustavi, Georgia 2005-2008 Private Tutor: Prepared students for USMLE Step 1& 2 exams (USA Medical Licensing exams) Health Educator (Reproductive Health, Women’s Health and Prevention of Diseases)



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