Clinical Research Medical

Alla Gourov, M.D.

*** ***** **** ***: *H Brooklyn, New York 11230 • Phone: 718-***-**** • Email: ****.******@*****.***

SUMMARY

Senior medical professional with over 20 years of medical research experience and over 10 years managing clinical trial operations (Phases I - IV). I am seeking a role where I can continue building on a career managing clinical trial operations.

EXPERIENCE

Biotrial Inc. Newark, NJ

Clinical Pharmaceutical Unit Associate Director June 2019 – November 2019

Ensure smooth functioning of the CPU concerning the performance of services provided and the overall good functioning of the unit.

Supervise the conduct of studies and ensure that they are high quality and delivered in a timely manner, according to Sponsor requirements. Additionally, ensure compliance with the applicable regulations and internal procedures.

Ensure the operational management of all the staff and resources of the CPU including organization and management, qualified staff selection, etc.

Provide support to the CPU principal investigator(s) and clinical research physician(s) to help ensure the quality of the studies conducted, participants’ safety, quality of data collected, and compliance with medical and ethical standards, and Good Clinical Practices.

Participate in sponsors' meetings and discussions.

Participate in the feasibility assessment of proposed studies (on a technical and quantitative point of view as well as regarding the access to the target population).

Ensure that the medical, clinical and recruiting staff coverage is sufficient to ensure the safety and proper conduct of studies.

Accomplish efficient planning and forecasting for the CPU.

Develop and implement the most efficient work methods.

Propose and participate in the development and implementation of new techniques and operating procedures.

Proactively propose actions to ensure high quality of services provided.

Work in compliance with applicable regulations, Good Clinical Practices and Biotrial internal procedures.

Supervise directly or indirectly the staff working in applicable units and assigned to Biotrial studies.

Clinilabs Inc. New York, NY

Clinical Research Operations Manager July 2014 – Feb 2019

Overall management of all clinical research operations, ensuring regulatory compliance and adherence to GCP/ICH guidelines

Manage hiring, provide training and supervision to over 30 CRCs, RAs, research technicians and evaluate staff performance

Develop customized in-service training for site employees for upcoming trials including subjects such as “Managing Behavior of Mentally Disturbed Patients”

Review clinical trial protocols and prepare site staff in the conduct of all protocol-related activities

Attend site initiation meetings, investigator meetings, and meetings related to clinical research activities

Ensure that site facilities and staff are adequate to meet demands of clinical trials conducted at the site

Oversee all investigational drug and device handling and storage

Host of site visits and other sponsor visits as needed

Oversee completion of CRFs, maintenance of source documents, ensure timely completion of DCFs

Perform physical examinations, ratings and other exams with patients and study subjects as needed

Collect data from patients and study subjects, and provide adequate documentation of study-related activities

Obtain and process biological samples from patients and study subjects, provide adequate documentation as needed

Supported operation of clinical trials for companies including:

AbbVie, Alder Biopharmaceuticals, Alkermes, AstraZeneca, Edgemont Pharmaceuticals, Ferring Pharmaceuticals, Fresca Medical, Janssen Scientific Affairs, Jazz Pharmaceuticals, Purdue Pharma, Roxane Laboratories, Parexel, Takeda Pharmaceutical, Sunovion Pharmaceuticals, Eisai Inc, Adare Pharma, Actelion Pharma, US WorldMeds, SAGE Pharma, Novartis, Sequential Inc, BioMerieux, Actelion Pharma

SUNY Downstate Medical Center, Department of Psychiatry Brooklyn, NY

Clinical Research Specialist – Sub Investigator Dec 2006 – Mar 2014

Investigated various antipsychotic medications for research studies

Initiated study protocols, patient recruitment, retention, continuous assessments, ratings, data collection and study related documents. Followed established clinical study standards and procedures to conduct clinical research studies

Developed procedures and tools for data collection as needed

Applied knowledge of company policies and standard practices to resolve problems

Compiled and maintained regular status reports of Study progress and study specific timelines and ensures information is provided to Clinical Study Team

Developed study documents including informed consent forms

Maintained open communication channels with study sponsors and members of the study team

In-service training to clinicians and other medical staff for available protocols and eligibility criteria

Monitored patients for side effects, reported occurrences

Supported operation of clinical trials for companies including:

Merck Sharp & Dohme Corp, AstraZeneca, Schering-Plough, Johnson & Johnson, Solvay Pharmaceuticals, Pfizer, Sunovion Pharmaceuticals, Hoffmann-La Roche, Sanofi Aventis, Lundbeck, Massachusetts General Hospital, Ortho-McNeil Janssen Scientific Affairs, Otsuka Pharmaceutical Development, Neurocrine Biosciences, Corcept Therapeutics

Certificates of completion of training: MINI plus, SCID, PANSS, NSA, SFS, CGI, CDSS, BARS, SAS, AIM, HAMA, MADRS, C-SSRS, CogFu, UPSA, MATRIX

Clinical Trial Participation

Indication

Phase 1

Phase 2

Phase 3

Phase 4

Device

Observation

Schizophrenia

2

3

15

1

Major Depressive Disorder with Psychotic Features

2

Schizoaffective disorder

2

Major depression

3

4

2

Bipolar disorder

4

Migraine

1

Social Anxiety

1

Asthma

1

Insomnia

19

5

Suicidal Ideation

1

Alzheimer’s Disease

2

2

2

Sleep Apnea

6

2

1

Human Abuse Liability

2

Lactose intolerance

2

Leg cramps

1

1

FIH

4

Jet lag

1

Epilepsy

1

1

Memory screens

N/A

SUNY Downstate Medical Center, Department of Pediatric Neurology Brooklyn, NY

Research Volunteer 2005 – 2006

Kings County Community Hospital Department of Medicine Brooklyn, NY

Volunteer 2004 – 2005

Mount Sinai Medical Center Department of Molecular Biology New York, NY

Research Associate 1996 – 1998

Introduced the Alzheimer’s disease into the mouse gene (knock in Swedish mutation into mouse stem cells).

Developed animal models (mice) for the Alzheimer’s disease.

Produced targeted mutations in embryonic stem cells for gene knockout experiments.

Analyzed DNA by Southern Blotting or PCR for detection of targeted mutations.

Detected expression by RNAs protection, Northern and Western Blots.

Mount Sinai Medical Center Department of Psychiatry New York, NY

Research Volunteer 1995 – 1996

Institute of Virology Clinical Department Moscow, Russia

Instructor

Provided advanced training for medical practitioners in the diagnosis and treatment of the Cytomegalovirus infection

House Staff M.D.

Intensive care of infectious diseases

Research Associate

Contributed to studies of new methods for the treatment of infertility and immunological disturbances due to the Cytomegalovirus and Herpes Infections.

EDUCATION

BLS 2019

CITI Course 2006, 2009, 2012,2018

Protection of Human Research Subjects

ECFMG Certificate 2005

USMLE Step 1

USMLE Step 2

Clinical Skills Assessment

First Medical Sechenov’s Institute Moscow, Russia

Doctor of Medicine

LAB SKILLS

Molecular biology PCR, DNA, RNA hybridization, Northern Blot and Southern Blot Analysis

Immunoassay ELISA, Western Blot

Protein chemistry PAAG Electrophoresis

Tissue culture techniques Maintenance of different types of cells: HeLa, Embryonic stem cells

Virology techniques Virus reproduction in permissive tissue culture and transformation of cells by viruses and DNA fragments

LANGUAGES

Fluent in Russian and French

Publications and references upon request

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