Обязанности и достижения:
- работа с протоколами различных компаний (исследования в области онкологии);
- организация всех процедур связанных с лечением пациентов,
- своевременное внесение данных в системы IWRS и eCRF
- наличие сертификатов GCP (Good Clinical Practice)
Участие в клинических исследованиях:
1) 2011- настоящее время: “Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of Subjects with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens”
2) 03.2012-настоящее время: “A randomized, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer.”
3) 05.2021-08.2020: “A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma”
4) 05.2013-03.2014: “A randomized, open-label, phase II study of the IDO inhibitor INCB024360 versus tamoxifen for subjects with biochemicak-recurrent-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer following complete remission with first-line chemotherapy”
5) 06.2013-настоящее время: “A Phase II Randomized, Multi-Centre, Open Label, Active-Controlled, Dose-Finding Trial of F-627 in Women with Breast Cancer Receiving Myelotoxic Chemotherapy”
6) 12.2013-11.2016: “Prevention of Recurrence of Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTM Treatment”
7) 01.2014-11.2019: “A Randomized, open-Label sturty comparing the combination of yoNDELts and DoXtL/cAELyx with Doxtt/cAELYX Monotherapy for tlhe Treartment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer”
8) 05.2014-05.218: “International, multicenter, open-label, Phase II study efficacy and safety of multiple doses of IMAB362 in patients with advanced adenocarcinoma of the stomach or the lower esophagus”
9) 31.08.2014-28.08.2015: “Phase II b randomized, double-blind, parallel group, placebo-controlled, dose finding study in colorectal cancer patients receiving 5-FU-based chemotherapy to assess the efficacy of different doses of s.c. elsiglutide in the prevention of chemotherapy induced diarrhea (CID)”
10) 05.2015-08.2020: “A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers”
11) 06.2015-08.2020: “A Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)”
12) 08.2016-11.2019: “A Phase III, Multicenter, Randomized, Open-Label Study of Avelumab (MSB0010718C) Alone or in Combination with Pegylated Liposomal Doxorubicin (PLD) versus Pegylated Liposomal Doxorubicin Alone in Patients with Platinum-Resistant/Refractory Ovarian Cancer”
13) 08.2016-25.09.2019: “A randomized, open-label, multicenter, phase III study to evaluate the efficacy and safety of avelumab (MSB0010718C) in combination with and/or following chemotherapy in patients with previously untreated epithelial ovarian cancer”
14) 05.2017-настоящее время: “A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy”
15) 07.2017-настоящее время: “A Randomized, Open-Label, Phase III Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer”
16) 08.2017-04.2020: “A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.”
17) 01.2019-настоящее время: “A Randomized Controlled, Open label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine versus Gemcitabine alone in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment”
18) 07.2019-настоящее время: “A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer”