Игорь

CLiNICAL RESEARCH ASSOCIATE
Ihor V. Andrushchak

education

Specialist in Economic of Enterprises, 2010
Kyiv National University of Trade and Economics, Ukraine

Specialist Dental Technician, 1997
Kyiv Medical College #4, Ukraine

WORK EXPERIENCE

2021 – till present CRA II
2019 – 2021 Self-employed (medical/pharmaceutical industries)
2016 – 2019 CRA II
2015 – 2016 Senior lab assistant
2013 - 2015 Self-employed
2004 – 2013 Clinical research associate
2001 – 2003 Technical assistant to director
2000 – 2004 Sales manager
1996 – 1999 Dental technician

THERAPEuTIC EXPERIENCE

Nervous System/Sense Organs: Multiple Sclerosis – 2016-2019
Circulatory: Heart Failure, Coronary Artery Disease (CAD) – 2005-2011
Musculoskeletal: Osteoarthritis and Rheumatoid Arthritis – 2008-2009
Oncology: Breast Cancer - 2011-2013
Oncology: Chronic Lymphocytic Leukaemia (CLL) – 2011-2013
Oncology: 1.Checkpoint inhibitor-naïve; 2. Advanced squamous cell non-small cell lung cancer (NSCLC); 3. Advanced squamous NSCLC; 4. Squamous cell cancer of the head and neck (SCCHN); 5. Advanced renal cell carcinoma (RCC); 6. Advanced cervical cancer; 7. Advanced soft tissue sarcoma limited to pleomorphic undifferentiated sarcoma, de-differentiated liposarcoma, synovial sarcoma, and myxofibrosarcoma; 8. Advanced non-microsatellite instability high (non-MSI-H) colorectal cancer (CRC); 9. Checkpoint inhibitor-naïve mCRPC with known homologous recombination repair (HRR); 10. Cutaneous melanoma – 2021 - 2022
Oncology: Squamous Cell Carcinoma of Head and Neck (SCCHN) with PD-L1 positive and PD-L1 negative cohorts – 2021-2022

Oncology: 1. NSCLC and cervical cancer; 2. Melanoma – 2021-2022
Oncology: 1. Non-Small Cell Lung Cancer (NSCLC); 2. Squamous Cell Carcinoma of Head and Neck (SCCHN); 3. Ovarian Cancer; 4. Small Cell Lung Cancer (SCLC); 5. Diffuse Large B Cell Lymphoma; 6. Cholangiocarcinoma; 7. Hepatocellular Carcinoma (HCC); 8. Triple Negative Breast Cancer; 9. Cervical Cancer; 10. Gastroesophageal Junction Cancer and Gastric Cancer – 2021-2022

Professional experience

CRAII 2021-2022

CRAII: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms:

Performed initiation, interim/remote monitoring visits and site management activities for 2 sites in Ukraine, according to GCPs and company/Sponsor’s SOPs. Performed drug accountability activities and assessed the safety of subjects and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in weekly TCs with the international management. Uploading study/site documents in eTMF. Performed completeness of eTMF and performed reconciliation.

CRAII: Phase 1 open-label, first-in-human, multi-center, dose escalation and dose expansion study of Investigational product administered alone (Module A) or in combination with pembrolizumab (Module B) in patients with advanced solid tumors

Performed initiation, interim/remote monitoring visits and site management activities for 2 sites in Ukraine, according to GCPs and company/Sponsor’s SOPs. Performed drug accountability activities and assessed the safety of subjects and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in weekly TCs with the international management. Uploading study/site documents in eTMF. Performed completeness of eTMF and performed reconciliation.

CRAII: A Phase 2 Open-Label Trial To evaluate efficacy of combination between Investigational product 1 + Investigational product 2 and Investigational product 1 + Investigational product 3 in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Performed initiation, interim/remote monitoring visits and site management activities for 2 sites in Ukraine, according to GCPs and company/Sponsor’s SOPs. Performed drug accountability activities and assessed the safety of subjects and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in weekly TCs with the international management. Uploading study/site documents in eTMF. Performed completeness of eTMF and performed reconciliation.

CRAII: A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients with Unresectable or Metastatic Neoplasms

Performed initiation, interim/remote monitoring visits and site management activities for 2 sites in Ukraine, according to GCPs and company/Sponsor’s SOPs. Performed drug accountability activities and assessed the safety of subjects and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in weekly TCs with the international management. Uploading study/site documents in eTMF. Performed completeness of eTMF and performed reconciliation.

CRAII 2016-2019

CRA II: Clinical Research Associate on a Phase III, safety and efficacy study evaluating the use of IMP for the treatment of Relapsing Multiple Sclerosis.
Perform interim monitoring visits and site management activities for 9 sites in Ukraine, according to GCPs and Company SOPs. Perform drug accountability activities and assessed the safety and efficacy of study IP. Ensure protocol and regulatory compliance. Establish and maintain regular contact with sites. Trained and work with CASCADE, RDC 5.1 and other vendor’s systems.

CRA II: Clinical Research Associate on a Multicenter, Open-Label, Extension Study to Evaluate the
Long-Term Safety and Efficacy of DAC HYP Monotherapy in Subjects With Multiple Sclerosis.
Perform interim monitoring visits and site management activities for 3 sites in Ukraine, according to GCPs and Company SOPs. Perform drug accountability activities and assessed the safety and efficacy of study IP. Ensure protocol and regulatory compliance. Establish and maintain regular contact with sites. Trained and work with CTMS and Oracle RDC and other vendor’s systems.

CRA II: Clinical Research Associate on a Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of IP in Patients with Primary Progressive Multiple Sclerosis (PPMS).
Perform interim monitoring visits and site management activities for 3 sites in Ukraine, according to GCPs and Company SOPs. Perform drug accountability activities and assessed the safety and efficacy of study IP. Ensure protocol and regulatory compliance. Establish and maintain regular contact with sites. Trained and work with CTMS and Medidata RAVE and other vendor’s systems.

CRA 2004-2013

CRA: Clinical Research Associate on a global, phase III, Coronary Artery Disease (CAD) study. Performed pre-study, initiation, interim monitoring visits and site management activities for 11 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Participated in CRA and Investigator Meetings. Established and maintained regular contact with sites.

CRA: Clinical Research Associate (Outsourced) on a global, phase III, Chronic Systolic Heart Failure study. Performed pre-study, initiation, interim monitoring, close-out visits and site management activities for 5 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Participated in CRA and Investigator Meetings. Established and maintained regular contact with sites.

CRA: Clinical Research Associate (Outsourced) on a global, phase IV, Osteoarthritis and Rheumatoid Arthritis study. Performed interim monitoring visits and site management activities for 3 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites.

CRA: Clinical Research Associate (Outsourced) on a global, phase III, Breast Cancer study. Performed interim monitoring visits and site management activities for 3 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites.

CRA: Clinical Research Associate on a global, phase III, Coronary Artery Disease (CAD) study. Performed pre-study, initiation, interim monitoring visits and site management activities for 10 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites.
Participated in CRA and Investigator Meetings.

CRA: Clinical Research Associate on a global, phase III, Relapsing Multiple Sclerosis study. Performed interim monitoring visits and site management activities for 5 sites in Belarus, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in CRA and Investigator Meetings.

CRA: Clinical Research Associate (Outsourced) on a global, phase III, Chronic Lymphocytic Leukaemia (CLL) study. Performed initiation, interim monitoring, preparations for close-out visits and site management activities for 10 sites in Ukraine, according to GCPs and global SOPs. Performed drug accountability activities and assessed the safety and efficacy of study IP. Ensured protocol and regulatory compliance. Established and maintained regular contact with sites. Participated in CRA and Investigator Meetings.

Clinical Trial Experience

Circulatory: A randomized, double-blind, placebo-controlled study for Systolic Heart Failure Treatment with the IMP – 6 years

Circulatory: A randomized, double-blind, placebo-controlled study of IMP in Chronic Heart Failure, mild hospitalized and survival study patients with Heart Failure – 5 years

Circulatory: An international, multi-center, randomized, double-blind study to compare IMP with placebo in reducing mortality and cardiovascular events in patients with stable Coronary Artery Disease (CAD) and Left Ventricular Systolic Dysfunction – 3 years

Circulatory: A study assessing the morbidity-mortality benefits of the IMP in patients with Coronary Artery Disease (CAD) – 3 years

Musculoskeletal: A multi-center, double-blind, parallel-group, placebo-controlled study of the efficacy and safety of IMP in patients with Osteoarthritis and Rheumatoid Arthritis – 1 years

Nervous System/Sense Organs: A phase III, safety and efficacy study evaluating the use of IMP for the treatment of Relapsing Multiple Sclerosis – 1 years

Nervous System/Sense Organs: A Multicenter, Open-Label, Extension Study to Evaluate the
Long-Term Safety and Efficacy of DAC HYP Monotherapy in Subjects With Multiple Sclerosis – 3 years

Nervous System/Sense Organs: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of IMP in patients with MS – 3 years

Oncology: A phase III, double-blind, randomized, parallel-group, active-controlled study to compare the efficacy and safety of IMP in patients with Early Breast Cancer – 1 year

Oncology: A phase III, open-label, randomized study of IMP added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide combination in patients with Relapsed Chronic Lymphocytic Leukaemia (CLL) – 1 year

Oncology: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms – 1 year

Oncology: Phase 1 open-label, first-in-human, multi-center, dose escalation and dose expansion study of Investigational product administered alone (Module A) or in combination with pembrolizumab (Module B) in patients with advanced solid tumors – 1 year

Oncology: A Phase 2 Open-Label Trial To evaluate efficacy of combination between Investigational product 1 + Investigational product 2 and Investigational product 1 + Investigational product 3 in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck – 1 year

Oncology: A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients with Unresectable or Metastatic Neoplasms – 1 year

Professional TRAINIGS

Completed CRO Clinical Foundation Program, May 2016
Completed CRA Workshop: Sponsor Clinical Foundation Program, Sep. 2008.

Completed “Conducting Clinical Trials - QA Management” training, 2005.
Attended the 1st Scientific Practical Conference "Clinical Trials of Medicinal Products in Ukraine", MoH of Ukraine, 2006.
Completed GCP Legislative and Regulatory Requirements of Clinical Trials of Medicinal Products International Foundation of Clinical Research training, 2007, Canterbury, UK.
Attended the 3rd Scientific Practical Conference "Clinical Trials in Medicinal Products in Ukraine", MoH of Ukraine, 2008.
Attended and completed a “Monitoring Essential Skills” Workshop, Sponsor Workshop, 2012.
Completed GCP Clinical Trial Regulations, State Expert Centre of MoH of Ukraine, 2012.
Trained in New Order of Conduction of Clinical Trial Medical Products and Expertise of Clinical Trial Materials.
Trained in Life/Time Coaching.
Trained in various EDC/eCRF systems.
GCP (E6) R2

Computer Experience

MS Word, MS Excel, MS PowerPoint, MS Access, MSTeams.

Languages

Mother tongue: Russian/Ukrainian. Fluent in English

PERSONAL DATA
Place and Date of Birth:
Kiev (Ukraine), 26 February 1976.
Nationality: Ukrainian
Address & phone number:
16, Liskivska str., Kiev, Ukraine;
Mob: [відкрити контакти](див. вище в блоці «контактна інформація»), e-mail: [відкрити контакти](див. вище в блоці «контактна інформація»)