This document provides a summary of Tatiana B. Lance's professional profile, education, skills, work experience, therapeutic experience, publications, and presentations. She has over 20 years of experience in clinical research and medicine obtained in both Russia and the United States. Her most recent role is as a Central Monitoring Associate for INC Research, where she is responsible for remote monitoring of clinical trials. She aims to obtain a challenging position with a reputable CRO commensurate with her education and experience in bringing new drugs to market and protecting research subjects.
Clinical Research Physician Seeks Challenging CRO Position
1. Tatiana B. Lance, MD
Physician and Clinical Research Professional
512-484-2712 DrTatianaVB@yahoo.com Austin, TX
Professional Profile
I trained as a medical doctor in Russia and now I have a diverse clinical research
background with multi-study coordination, regulatorydocumentmanagement,
and extensive site monitoring experience. I’m passionate about bringing newdrugs
to market, protecting the welfare of research subjects, and improving globalhealth
outcomes through scientific research. My career goalis to obtain a challenging
position with a reputableCRO, commensuratewith my education.
Education
1995 - SaratovState Medical University - Russian Federation
Doctor of Medicine MD - InfectiousDiseases and Epidemiology Fellowship
1993 - SaratovState Medical University - Russian Federation
Doctor of Medicine MD - InternalMedicine (summa cum laude)
Skills
Fluent in English and Russian; proficientin German
Expertise with CFR, ICH, GCP, and HIPAA regulations
Broad knowledge of clinical indications, including oncology
Experience conducting multiple PhaseII-IV drug and device trials
Proficientwith variousCTMS, EDC, and IWRS systems
Outstanding organizationaland critical thinking skills
Extensive experience with the reporting and documentation of SAEs
2. Work Experience
INC Research, LLC March 2016-present
Austin, TX
Central Monitoring AssociateII
Responsible for remote monitoring and site management of Phase II-IV clinical research
studies, conducting all types of remote monitoring visits (PSSVs, IMVs, etc.).
Maintains effective communication with sites, establishing solid relationships with
Investigators and all other site staff.
Assists with feasibility and patient recruitment strategies.
Ensures sites have the required study training and are compliant with the protocol and
regulatory guidelines.
Monitors site performance metrics and patient enrollment, and implements action plans
for improvement.
Remotely reviews electronic data submitted by sites and assists in resolving queries.
Completes and submits visit reports according to SOPs/Work Instructions (WI) or Sponsor
requirements.
Ensures eTMF is updated for Essential Documents, etc.
Documents and tracks the resolution of all outstanding issues.
Attends Investigator meetings, clinical monitoring staff meetings, project team meetings
and clinical training sessions.
Manages assigned sites via calls and emails to ensure the integrity of clinical data.
Understands the drug development process, Good Clinical Practices (GCP) and relevant
regulations.
Mentors less experienced CMAs.
Seton Dell MedicalSchoolStroke Institute August2015 –March 2016
Austin, TX
Clinical Research Coordinator
Collaborated with primary investigator, sponsor and research staff to plan, conduct and
evaluate project protocols. Monitored and reported on progress of projects.
Assisted with the recruitment, selection, scheduling, and monitoring of research
participants.
Managed the reporting of serious adverse events, compliance, and other participant-
related issues.
Coordinated the preparation and delivery of departmental communications,
presentations and marketing/educational materials.
Collaborated to ensure compliance with applicable regulations and standards. Assisted
with responding to and preparing for audits.
Participated in study protocol development. Prepared and presented IRB proposals.
3. Served as a liaison between clinical setting and research investigators to ensure clear
communication and study progress. Ensured all research-involved staff complete
required human subjects protection training.
Entered data into study specific databases. Ensured data remained clean and coded
appropriately. Maintained impeccable study records. Maintained log tracking progress of
all trauma related research studies and reports on progress to appropriate
departments/groups.
Assisted with finding and applying for research funding.
Emergency Service Partners, LLC January2014 –July 2015
Austin, TX
Clinical Research Specialist
In collaboration with the PI and Director, was responsible for site operations.
Supervised work of Clinical Research Coordinators, Research Nurses, Clinical Research
Assistants, and performed Clinical Research Coordinator functions.
Communicated with the key staff from study sites (hospitals/clinics) including Nursing,
Lab, Pharmacy and Health Information Management prior to conducting any study. Met
with study staff to maintain open communication and fostered networking and
relationships.
Provided training to HPCR and Institutional staff as needed.
Provided leadership and guidance to site personnel, and ensured all employees were
following policies, procedures and protocols.
Managed projects and ensured timely project completion, including data cleanup.
Determined and communicated work assignments to site personnel including
enrollment coverage, outpatient visits, chart review/data transcriptions, and data
queries.
Scheduled site personnel and was responsible for site employee relations, supervision,
performance management, and development.
Responded to site emergencies, issues, concerns or problems as needed.
Travelled to all clinical research sites as needed to complete related tasks.
Adhered to ICH/GCP, HIPAA, IATA, FDA regulations, and HPCR procedures, maintained
strict confidentiality of patients, research subjects, employees and company
information, and maintained constant awareness of subject safety and dignity.
Seton Healthcare Family January2011 – January2014
University MedicalCenter-Brackenridge
Austin, TX
ICU/ED Trauma Tech
Performed and documented patient care procedures including: vital signs, orthostatic
vitals, weights, intake/output, POC testing, and phlebotomy.
Assisted with patient positioning during procedures and exams, used universal
precautions, performed simple wound care, lead placement for EKG monitoring.
4. Maintained spinal immobilization, application and removal of hare traction splints,
application of various splints and casts, catheterization of male and female patients,
suture and staple removal, crutch fitting and instructions.
Assisted with traumas and cardiac arrests, used sterile technique with specialty and
chest-tube trays set-ups, assisted with patient care on arrival of ambulances.
Performed clerical duties, processed all written orders by physicians.
Generated initial patient chart to facilitate immediate patient care at the bedside. Kept
patient records current.
Assisted RN with transports of patients with appropriate safety measures.
Adhered to departmental safety and security precautions. Took an active part in the ED
disaster plan (Hazmat).
Maintained department equipment. Demonstrated a good working knowledge of all
department equipment such as wheelchairs, stretchers, cast saws, ring cutter, oxygen
tanks etc.
Maintained established departmental policies and procedures. Followed environmental
and infection control standards.
Actively participated in orientation of new personnel, attended staff meetings, and in-
services. Enhanced professional growth and development through participation in
educational programs.
Maintained compliance with hospital's Standards of Performance and with the hospital's
Service Excellence Program.
Emergency Service Partners, LLC April 2012 –December 2013
Austin, TX
Clinical Research Assistant
Under direction of the Clinical Research Coordinator, performed clinical and
administrative tasks.
Completed protocol specific procedures including obtaining informed consent, medical
history, vital signs, biometrics, preparing exam rooms and equipment.
Followed study protocols, accurately recorded and documented research related data,
completed necessary forms and records.
Assisted CRC in creating source documents, prepared subject research charts, and
screened potential research subjects.
Facilitated study monitor visits.
Accurately performed biological specimen collection, processing, transport, and ensured
proper disposal.
Scheduled follow up visits for subjects and coordinated investigator coverage.
Communicated with study subjects through e-mail, mail, phone, fax and in person.
Travelled to all clinical research sites as needed to complete related tasks.
Adhered to ICH/GCP, HIPAA, IATA, FDA regulations, and HPCR procedures, maintained
strict confidentiality of patients, research subjects, employees and company information,
and maintained constant awareness of subject safety and dignity
5. Therapeutic Experience
Cardiovascular
CHF/MI/HTN
CNS-Neurology
Alzheimer’s Disease
Seizure Disorders
Stroke
IntracranialHemorrhage/Thrombolysis
Endocrinology
Diabetes Miletus
InfectiousDiseases/Immunology
Sepsis/Cellulitis/ Appendicitis/AIDS
Vaccines
Oncology
Publications & Presentations
The American Journalof Emergency Medicine
Author: MichaelMouw MD
Co-Authors: Tatiana Balatiouk-LanceMD; Lawrence H Brown, PhD,MPH&TM
Title: "Can physician and patient gestalt lead to a shared decision to reduce
unnecessary radiographyin extremity trauma?”
The University of Texas at Austin Emergency Medicine, Renee Dillie, MD, Brian
Price, MD, Annette O. Arthur, PharmD, Kelly Maytubby, NREMT-P, CCEMTP,FP-
C,Joe Flores,RN, Tatiana V.Balatiouk-Lance,Stephen H.Thomas,MD MPH "Video
Laryngoscopyfacilitated intubation success in helicopter EMS"