Ст. специалист по клиническим исследованиям

Описание

 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.

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 .

 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 Leaders.

 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 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 successful audit 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 participations.

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, Cervica - 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