Специалист по клиническим исследованиям I уровня

Описание

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Yulia Mirnaya
RUS-Home -Based Sr . CRA II - LCRA, Associate Clinical Operations Team Leader (CTL) ,
Central Report Reviewer (CRR)

Phone #: +7 (919) 965- 31-42
E -mail: yuliaw@bk.ru

Biography born 17/01/1977 based in Saint - Petersburg Russia
Yulia Mirnaya had 10.5 years of experience with Syneos Health/inVentiv Health/INC Research and drug
study phase experience.
Additionally, Yulia Mirnaya has 18 years of experience in the Contract Research
Organization (C RO) Industry as a Project Administrator, CRA I, CRA II, CRA III, Senior CRA, Associate
Clinical Operations Team Leader, Sr . CRA II - LCRA , Central Report Reviewer (CRR)
and drug study phase experience from Phase II -IV in several therapeutic areas . Handed w ith 2 Awards:
Business Unit/Department Key Contributor and Business Unit/Department High Performance Team. Willing
to assist others on projects/assignments, plus the ability and desire to learn more likes to improve this aid,
especially to new staff. Able to manage several studies and work under pressure. Demonstrates a strong
commitment to quality and continuous improvement.

Professional Experience
Sep 2022 – Aug 2024 Syneos Health
Central Report Reviewer (CRR)
Responsible for execution of Central Report Review activities on an assigned studies. Monitoring strategy
defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. S upport ing
development of annotated visit reports such as PSV s, SIVs , IMVs , COVs & Site Central Assessment
Notification Reports ( SCANs). Review ed the content and quality of site and central monitoring
documentation (site monitoring calls, site monitoring reports, si te central assessment notification reports,
site letters and pertinent correspondence), to ensured they represent site visits activities and conduct and
that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data
integrity. Document ed requested revisions and approvals in CTMS. Ensure d these deliverables are
provided according to company and/or S ponsor specifications, including delivery deadlines. Assesse d
factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
such as protocol deviation/violations/special Sponsor’s requirements and pharmacovigilance issues
documented in the report. Immediately communicate d/escalated serious issues to Clinical Trial
Manager/Project Manager . Document ed observations noted during reviews and ensured protocol
deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other
functional team members. Participate d in clinical monitoring/project staff meetings and attends clinical
training sessions according to the project specific requirements. Involve d in regular project discussion and
email correspondence to maintain the most up -to -date project status knowledge and progression.
S upport ed in CTMS activities such as Protocol Deviation management, Action Items management .

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Mar 2014 – Sep 2022 Syneos Health
Sr CRA II - LCRA
Involved in the following activities: IMVs, PSVs, SIVs, COVs, Pharmacy COVs, perform ing co -monitoring
visits, co -monitoring reports reviewing, monitoring reports reviewing, managing documents flow fulfillment,
participat ions in TCs, site management, Investigator Payments procedures, site staff training's, sites
preparation for an audits, mai ntaining the TMF documents, collection of essential documents,
communication with LECs, preparation and attendance at the site successful audits , 6 Sponsor audits, 6
internal audits, CAPA resolutions (Corrective and Preventive Actions) , co-monitoring visit s with Sponsor,
training's for newly onboarded junior CRAs.
P erform ed source data verification, initiates data query resolution and confirms resolution in timely manner.
Perform ed investigative site file reconciliation: requests any new and updated site- related essential
documents and reviews them for content, consistency with other documents, and compliance with
appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs),
and sponsor requirements. Keeping SDV bac klog in control for the sites. Assisting with the preparation of
study start -up materials and tools. Ensured that the subject safety and adverse events report ed to sponsor
and IRB/IEC. Maintain ed regulatory documentation of clinical trial. Communicat ed and work ed closely with
project leaders. Expressed ideas and information accurately and understandably in both oral and written.
Kept supervisor/lead informed of work assignments and progress. Act ed on requests, communicate d
information, and resolved problems in a timely manner. Successfully execute d on projects and business
goals on time and within budget. Prepar ation for Investigator’s meetings. Adhered to company policies and
procedures.
Also involved in the role of a Lead CRA (LCRA) on projects by providing direction and guidance to the
project’s team s, prepared trainings/study documents, coordinating all the monitoring activities, and
communicating the status to Project Leader s.
Dec 2012 - Dec 2013 Quintiles
Associate Cl inical Operations Team Leader
Experienced as a Team Leader in Multiple myeloma studies phase II -IV responsible for coordinating the
functional team members and their activities across Russia and Ukraine liaising with project leadership and
the Sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity,
supported in trips report s reviewing, TMF review) are met. Providing study status updates to team members
and project management, including interaction to resolve site issues and facilitate project timelines.
Participate d in clinical monitoring/project staff meetings and attended clinical training sessions according
to the project specific requirements. Provid ing oversight of Central Monitors, including completion of
training. Documented requested revisions and approvals in CTMS. Assessed factors that might affect
subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol
deviation/violations and pharmacovigilance issues documented in the report.

Feb 2011 - Dec 2013 Quintiles
Senior CRA
Involved in the following activities: IMVs, PSVs, SIVs, COVs, Pharmacy COVs, performing co -monitoring
visits, co -monitoring reports reviewing, monitoring reports reviewing, managing documents flow fulfillment,
participation in TCs, site management, Investigator Payments procedures, site staff training's, sites
preparati ons for an audits, maintains the TMF documents, collection of essential documents,
communication with LECs, supported in MVs reports reviewing, Preparation and attendance at the site of

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successful audit 1 Sponsor audit, 3 internal audi ts, co -monitoring visits with Sponsor, training's for newly
onboarded junior CRAs.
Performed source data verification, initiates data query resolution and confirms r esolution in timely manner.
Performed investigative site file reconciliation: requests any new and updated site- related essential
documents and reviews them for content, consistency with other documents, and compliance with
appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs),
and sponsor requirements. Keeping SDV backlog in control for the sites. Assist ing with the preparation of
study start -up materials and tools. Ensured that the subject safety and adver se events reported to sponsor
and IRB/IEC. Maintained regulatory documentation of clinical trial. Communicated and worked closely with
project leaders. Expressed ideas and information accurately and understandably in both oral and written.
Kept supervisor/ lead informed of work assignments and progress. Acted on requests, communicated
information, and resolved problems in a timely manner. Successfully executed on projects and business
goals on time and within budget. Prepar ation for Investigator’s meetings.

Dec 2009 - Feb 2011 ClinStar
CRA III
Involved in the following activities: IMVs, PSVs, SIVs, COVs, Pharmacy COVs, performing co -monitoring
visits, co -monitoring reports reviewing, monitoring reports reviewing, managing documents flow fulfillment,
partici pation in TCs, site management, Investigator Payments procedures, site staff training's, sites
preparation s for an audits, maintains the TMF documents, collection of essential documents,
communication with LECs, supported in MVs reports reviewing, Preparation and attendance at the site of
successful audits 5 Sponsor audits, 4 internal audits, co -monitoring visits with Sponsor, training's for newly
onboarded junior CRAs. Able to manage several studies. Demonstrated a strong commitment to quality
and continuous improvement.
Performed source data verification, initiates data query resolution and confirms resolution in timely manner. Performed investigative site file reconciliation: requests any new and updated site- related essential
documents and reviews them for content, consistency with other documents, and compliance with
appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs),
and sponsor requirements. Keeping SDV backlog in control for the sites. Assisting with the preparation of
study start -up materials and tools. Ensured that the subject safety and adverse events reported to sponsor
and IRB/IEC. Maintained regulatory documentation of clinical trial. Communicated and worked closely with
project l eaders. Expressed ideas and information accurately and understandably in both oral and written.
Kept supervisor/lead informed of work assignments and progress. Acted on requests, communicated
information, and resolved problems in a timely manner. Successfully executed on projects and business
goals on time and within budget. Prepar ation for Investigator’s meetings. IMs participations. Adhered to
company policies and procedures.


Nov 2008 - Dec 2009 ClinStar
CRA II
Involved in the following activities: IMV s, PSVs, SIVs, COVs, Pharmacy COVs, performing co -monitoring
visits, co -monitoring reports reviewing, monitoring reports reviewing, managing documents flow fulfillment,
participation in TCs, site management, Investigator Payments procedures, site staff training's, sites
preparation for audits, maintains the TMF documents, collection of essential documents, communication
with LECs, supported in MVs reports reviewing, Preparation and attendance at the site of successful audits

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1 Sponsor audit, 2 internal audits, CAPA resolution, co -monitoring visits with Sponsor, training's for newly
onboarded junior CRAs.

Performed source data verification, initiates data query resolution and confirms resolution in timely manner.
Performed investigative site file reconciliation: requests any new and updated site- related essential and non-
essential documents and reviews them for content, consistency with other documents, and compliance with
appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs),
and sponsor requirements. Keeping SDV backlog in control for the sites. Assist ing with the preparation of
study start -up materials and tools. Ensured that the subject safety and adverse events reported to sponsor
and IRB/IEC. Maintained regulatory documentation of clinical trial. Communicated and worked closely with
project leaders. Expressed ideas and information accurately and understandably in both oral and written.
Kept supervisor/lead informed of work assignments and progress. Acted on requests, communicated
information, and resolved problems in a timely manner. Successfully executed on projects and business
goals on time and within budget. Prepar ation for Investigator’s meetings. IMs participations. Adhered to
company policies and procedures.

Jun 2007 - Nov 2008 ClinStar
CRA I
Involved in the following activities: IMVs, PSVs, SIVs, COVs, Pharmacy COVs, performing co -monitoring
visits, co -monitoring reports reviewing, monitoring reports reviewing, m anaging documents flow fulfillment,
participation in TCs, site management, Investigator Payments procedures, site staff training's, sites
preparation s for an audits, maintains the TMF documents, collection of essential documents,
communication with LECs, s upported in MVs reports reviewing, co -monitoring visits.
Perform ing source data verification, initiates data query resolution and confirms resolution in timely manner.
Perform ing investigative site file reconciliation: request ing any new and updated site- related essential and
non- essential documents and review ing them for content, consistency with other documents, and compliance
with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures
(SOPs), and sponsor requirem ents. Keeping SDV backlog in control for the sites.
Assisting with the
preparation of study start -up materials and tools. Ensured that the subject safety and adverse events reported
to sponsor and IRB/IEC. Maintained regulatory documentation of clinical tr ial. Communicated and worked
closely with project leaders. Expressed ideas and information accurately and understandably in both oral and
written. Kept supervisor/lead informed of work assignments and progress. Acted on requests, communicated
information, and resolved problems in a timely manner. Successfully executed on projects and business
goals on time and within budget. Prepar ation for Investigator’s meetings. IMs participations. Adhered to
company policies and procedures.

Nov 2005 - Jun 2007 ClinStar
Project Administrator

Administrative responsibilities within a clinical trial. Administrative support to the study team, project team meetings organization and reporting, study tracking logs maintenance, Sponsor communication with
regard to the project specific non-medical issues, participation in TC s, managing documents, IM s
participation s.

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Oct 2000 - Mar 2004 Bon Secours Hospital, Detroit, MI
Medical Billing Specialist
Contacted insurance companies, collected funds on outstanding balances.
Therapeutic Experience
CNS Psychiatry - CNS Psychiatry - Acute Mania
Cardiovascular - Coronary Syndrome, Acute
- Heart Failure, Congestive
- Varicose Veins
Dermatology - Dermatitis, Atopic
- Eczema
- Dermatology - Psoriasis
- Psoriasis
- Rheumatoid Arthritis
Endocrinology/Metabolism - Diabetes Mellitus
Gastroenterology - Diarrhea, Clostridium Difficile
Hepatology - Liver Disease
Immunology / Inflammatory - Lupus Erthymatosus, Systematic
Infectious Disease - Bronchitis
- Immunization, Clostridium Difficile
- Infection, Bacterial
- Infection, COVID -19
- Infection, Community Acquired Pneumonia, Acute
- Infection, Complicated
- Infection, Skin and Soft Tissue
Inflammatory Diseases - Inflammatory Diseases - Rheumatoid Arthritis
Oncology - Cancer, Cervical

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- Cancer, Multiple Myeloma
- Oncology - Metastatic Cancer
Respiratory - Asthma
Respiratory - Cystic Fibrosis
Skeletal Diseases - Rheumatoid Arthritis
Urology - Prostatitis

Languages
English - Speaking, Reading, Writing
Russian - Speaking, Reading, Writing
- Native
Professional Certifications & Licensures
Certificate in nursing Education
- Mar -2001
Education
2005 Professional Career Development Institute - United States
Diploma - Medical Climes Specialist