Dar’ya Buvaylo, RN, BScN

** ***** ****** **. ******: 647-***-****

Etobicoke, ON, M8V 0G1 ado4ak@r.postjobfree.com

Dear hiring manager,

I am writing to express my great interest in the Clinical Research Associate position. Considering my medical background and clinical research experience, I feel strongly that I would be a great fit for this position. The enclosed resume supports my qualifications and credentials. I аm a licensed Registered Nurse with experience in clinical research where I am involved in domestic and global multicenter phase I-III oncology clinical trials - working in collaboration with investigators, study teams, pharmaceutical companies, cancer centre’s, academic R&D institutions, and oncology groups. I have in-depth understanding of clinical research, study protocols, and monitoring procedures.

For the past years, I worked at Princess Margaret Cancer Centre, Toronto in a variety of oncological settings including medical/radiation oncology, palliative care, transplant, and hematological sites. Through this experience, I gained valuable hands-on skills and experience in delivery of clinical excellence by managing, monitoring, and caring for oncology patients in diverse settings – including clinical trial patients on solid tumor unit.

As you can see, I believe I have a great deal to offer, including:

• 4+ years of clinical experience including execution of domestic and global multicenter phase I-III clinical trials in oncology

• Understanding of drug development, clinical research, study protocols, monitoring procedures

• Knowledge of ICH/GCP guideline, GPP, and other applicable regulatory regulations

• Excellent communication, presentation, interpersonal, and critical thinking skills

• Ability to effectively manage time, prioritize and handle diverse challenging tasks

• Efficiency in fast-paced, high-pressure work environments demonstrating flexibility, excellent organization, problem solving, and leadership skills

• Ability to travel/drive a car as required

You will find me to be a highly organized professional who strives to continue to succeed and grow professionally. I am confident that given my experience, skills, motivation, and sense of responsibility, I can quickly become a productive member of your company and clinical research team. I would appreciate the opportunity to interview with you to further discuss my qualifications and learn about your company objectives.

Thank you in advance for your time and consideration. Sincerely,

Dar’ya Buvaylo

Dar’ya Buvaylo, RN

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Dar’ya Buvaylo, RN, BScN

33 Shore Breeze Dr. Mobile: 647-***-****

Etobicoke, ON, M8V 0G1 ado4ak@r.postjobfree.com

SUMMARY

Registered Nurse and Clinical Research professional with hospital-based clinical experience working in a variety of oncological settings: medical/radiation oncology, palliative care, transplant, and hematological sites

4+ years of clinical experience including execution of domestic and global multicenter phase I-III clinical trials in oncology

Knowledgeable in clinical research regulations and guidelines: ICH/ Good Clinical Practice

(GCP), Good Pharmacoepidemiological Practices (GPP), FDA and Health Canada TPD

Valued as a dynamic, highly motivated, compassionate, and proactive team-player

Recognized by peers, investigators and management for critical thinking, ability to take initiative and handle diverse, challenging tasks - focusing on details and demonstrating excellent organization, communication, time management, and leadership skills

Proven track record as a successful mentor

PROFESSIONAL EXPERIENCE

UHN – Princess Margaret Hospital, Toronto, Canada Jan. 2021– Present Clinical Research Coordinator III

• Contribute to site initiation visits and study conduct from institutional authorization to close- out visits in compliance with regulatory, ICH- GCP, Sponsor Standard Operating Procedures

(SOPs), study protocol, Site Monitoring Plan, and associated documents

• Work in collaboration with inter-disciplinary study teams to ensure subject’s safety, rights, and well-being are protected and study objectives, deliverables, and timelines are met

• Demonstrate strong knowledge and ability to navigate study protocol to avoid queries and deviations while maintaining clinical data completeness, quality, and integrity

• Identify, screen, and consent/re-consent clinical trial subjects with a strict adherence to study protocol eligibility criteria and in an accordance with GCPs, SOPs, institutional policy

• Coordinate subject visit schedules per study protocol (e.g. treatment visit, diagnostic and therapeutic procedures, physical exam, imaging exam, assessment of adverse events, safety monitoring, concomitant medication review, quality of life questionnaires, blood/urine/ pharmacokinetic/biomarker sample collection, other)

• Communicate with investigators and site staff on issue escalation and corrective actions related to protocol conduct, recruitment, retention, adverse event reporting and management, protocol deviations, completion of source documents (SD) and medical records

• Collaborate with Sponsor, Clinical Research Associate (CRA), Medical Monitor, and various cross functional team members regarding study related questions to ensure study procedures Dar’ya Buvaylo, RN

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and investigational treatment are in compliance with the protocol (e.g. dose modification, permanent treatment discontinuation, review of exam/test results, scans and RECIST reports)

• Responsible for subject clinical care, toxicity management, AE evaluation/reporting/grading per CTCAE and follow up until resolution, initiation of hospitalization as required, reporting of SAEs in compliance with GCP and ICH guidelines

• Report privacy and potential serious breaches where appropriate in accordance with applicable guidance

• Support preparation for audit readiness and required follow-up actions

• Support sponsor monitoring visits by providing all requested information

• Keep up to date with annual competencies, attend education sessions, and voluntarily participate in emerging oncology research conferences

• Demonstrate flexibility and excellent time management skills by meeting deadlines

• Recognised for ability to overcome adversity with respect to multiple trials with a continued proven ability to think analytically and critically through difficult and high-pressure situations while effectively solving problems

• Due to professional achievements, skills, and high-quality performance - was nominated as a member of the Clinical Research Unit Council where I have contributed to improvement in clinical practice, new hire orientation changes, and institutional SOPs revisions

• Mentored a nursing student acting as primary preceptor in his final consolidation placement UHN – Princess Margaret Hospital, Toronto, Canada Jan. 2019 – Dec. 2020 Registered Nurse, 17 B Medical/Radiation Oncology

• Shadowed clinical trial nurses and gained knowledge on:

- Site initiation and patient recruitment strategies to meet recruitment targets

- Sample collection, review of test results, patient physical and psychosocial assessment, vital signs monitoring, appropriate clinical data documentation

- Exposure to clinical data management systems to electronically capture, manage, and report clinical study data e.g. Case report form (eCRF)/RAVE, Electronic Data Capture (EDC), Patient-Reported Outcome (PRO)

• Gained oncology knowledge and experience by providing:

- care, monitoring, and clinical management for oncology patients with advanced cancers undergoing clinical trials, auto/allo bone marrow transplant, brachytherapy, radiation, chemotherapy, and immunotherapy

- care for oncology patients with immunodeficiency, febrile neutropenia, infections, sepsis, septic shock

- care for patients with chest, cholecystectomy, and nasogastric tubes (including insertion and removal); PTC, peritoneal, abscess, JP and Hemovac drains; nephrostomies, tracheostomies, gastrostomies

- management of patients with emergencies including but not limited to metabolic

(hypoglycemia, hyperglycemia, tumor lysis syndrome, hypercalcemia, hyponatremia, lactic acidosis, SIADH), neurologic (spinal cord compression, brain metastases, increased intracranial pressure, status epilepticus), cardiovascular (malignant Dar’ya Buvaylo, RN

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pericardial effusion, superior vena cava syndrome, myocardial infarction, cardiac tamponade), hematologic (disseminated intravascular coagulation, hyperleukocytosis, patients thrombosis, GVHD) emergencies

- starting and managing peripheral IV’s, CVC’s, and PICC lines & collection of daily blood work

• Acknowledged and appointed by the manager to train and act as preceptor to student nurses and new hires

• Valued team-player with demonstrated strong leadership, flexibility, adaptability, proven quick problem-solving abilities in the frequent role of “charge nurse” and ability to efficiently handle stressful, fast-paced environment in a positive manner UHN – Princess Margaret Hospital, Toronto, Canada Oct. 2018 – Jan. 2019 Registered Nurse, Nursing Resource Unit (NRU)

• Gained excellent time management, autonomy, and team work skills through floating to nine inpatient units

• Managed patients with surgical emergencies including bowel obstruction, perforation, gastrointestinal bleeding, and other

• Cared for patients prior to and post stem cell infusion CLINICAL EXPERIENCE

Kensington Gardens, Toronto, Canada Jan. – April 2018 3W – Long Term Care

UHN – Princess Margaret Hospital, Toronto, Canada Sep. – Dec. 2017 15B – Leukemia and Lymphoma Oncology Unit

Blessed Trinity Catholic School, Toronto, Canada Sep. 2016 – April 2017 Community Health Nursing

Mackenzie Health, Toronto, Canada Jan. – April 2016 C4North – Post Surgery Unit

Mount Sinai Hospital, Toronto, Canada Sep. – Nov. 2015 11 South – Orthopaedic & Oncology Unit

EDUCATION / PROFESSIONAL CERTIFICATION

Ryerson University, Toronto, Canada June 2018

Bachelor of Science in Nursing (BScN)/ Registered Nurse Diploma RN Registration with the College of Nurses of Ontario, Canada August 2018 Dar’ya Buvaylo, RN

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Heart and Stroke

Basic Cardiac Life Support (BCLS/BLS) Certification September 2018 DeSouza Institute, Toronto, Canada

Provincial Standardized Chemotherapy & Biotherapy Certification March 2020 CITI Program Clinical Research Training

GCP for Clinical Trials with Investigational Drug and Biologics (ICH Focus) August 2020

• ICH GCP standards

• FDA regulations

• Investigator and sponsor obligations

• New drug development

• Comparing ICH GCP E6 guideline and FDA regulations

• Adverse events detection and reporting

• Clinical trial monitoring and auditing

UHN – Canadian Cancer Trials Group Certification January 2021

• Health Canada Division 5 (Version 1)

• GCP Module 1 – Introduction to GCP (R2) (Version 3.1)

• GCP Module 2A – Investigator Responsibilities (R2) (version 3.1)

• GCP Module 2B – Investigator Responsibilities: Informed Consent (R2) (Version 3.1)

• GCP Module 3A – Research Ethics Boards (R2) (Version 3.1)

• GCP Module 3B – Ethics and Safety reporting (R2) (Version 3.1)

• GCP Refresher Training (R2) (Version 1)

• NIH – Protecting Research Participants Course

• TCPS2 – Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

• SOP training

Princess Margaret Hospital, Toronto Canada

Solid Tumor Malignancies June 2019

Advanced Malignant Hematology April 2019

Palliative Care April 2019

Introduction to Malignant Hematology March 2019

Management of deteriorating patient March 2019

Introduction to Oncology Feb. 2019

Oncology focused assessment Nov. 2018

TECHNICAL SKILLS

Proficient in Outlook, MS Office -Word, Power Point, Excel, Microsoft Teams, Acrobat Reader Worked with: IXRS, OPIS, RAVE, EDC, eCRF, iMedidata, EPR, CRR, PHS, SIP LANGUAGE CAPABILITIES

Fluent in written and verbal English, Ukrainian, and Russian

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