Alla Gourov, M.D.
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.
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
Major Depressive Disorder with Psychotic Features
Human Abuse Liability
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
Provided advanced training for medical practitioners in the diagnosis and treatment of the Cytomegalovirus infection
House Staff M.D.
Intensive care of infectious diseases
Contributed to studies of new methods for the treatment of infertility and immunological disturbances due to the Cytomegalovirus and Herpes Infections.
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
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
Fluent in Russian and French
Publications and references upon request