Serhii Kulish
Krosno
Summary
Dynamic and results-driven Senior Clinical Research Associate (SrCRA) with over nine years of experience in the clinical trials field. Specialized in conducting trials for various diseases, particularly in the fields of oncology, pulmonology, and cardiology. Experienced with clinical trial management, ensuring seamless progression from start to finish. Utilizes strategic planning and regulatory acumen to uphold compliance and project integrity. Track record of fostering effective team collaboration and achieving reliable outcomes. In June 2024, I successfully passed the state exam for knowledge of the Polish language for foreigners (level B1). Proficient in performing all types of visits from selection to close-out. I am fluent in Ukrainian (native), Russian (fluent), and proficient in English (intermediate). Well-acquainted with the principles of Good Clinical Practice and regulatory documents (ICH-GCP, GLP, GMP), which form the basis of any clinical trial. I hold a valid ICH-GCP certification until 2027. Experienced in using the following systems: CTMS, EDC (Medidata, eCaseLink), eTMF (Veeva v1.0 and V2.0, PhlexEview), IXRS (4G Prancer, Endpoint, Almac, S-Clinica), and IRT (Suvoda).
Skills: Clinical Trials Implementation and Monitoring Investigational Site, Management Data Verification and Accuracy Team Leadership and Mentoring Regulatory Compliance (ICH-GCP, GLP, GMP), Strategic Planning and Coordination.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
ICON, Formerly PRA Health Sciences
04.2021 - Current
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to [Type] management verbally and through technical documentation and presentations.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
Clinical Research Associate 3
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
09.2019 - 03.2021
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Liaised with clinical project leader to effectively resolve study-related issues.
Clinical Research Associate 2
COVANCE CLINICAL DEVELOPMENT SERVICES CRO,
02.2016 - 09.2019
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
Clinical Research Associate 1
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
06.2015 - 01.2016
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Trainee Clinical Research Associate
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
08.2014 - 06.2015
- Learned new materials, processes, and programs quickly.
- Participated in on-the-job training, working closely with supervisors and coworkers and asking appropriate questions.
- Attended training courses to build understanding of processes, techniques, and industry.
- Supported departmental tasks to increase understanding of industry processes.
- Supported organizational objectives with help from existing employees.
- Performed administrative functions, answering phones and filing paperwork in support of department.
- Assisted in creating marketing materials, enabling more effective customer outreach.
- Supported implementation of new technologies, leading to more efficient workflows.
Education
General pathologist -
National Medical University named after A.A. Bogomolets
06.2004
Doctor Assistant -
Communal Institution Nizhyn medical college
03.1994
Skills
- Medical Assisting
- Clinical Administration
- Administrative Assistance
- Clinical Research
- Internal Medicine
- Medical Diagnostics
- Communication
- Medical Terminology
- Medical Review
- Analytical Skills
- Teamwork
- Clinical Monitoring
- Patient Safety
- Clinical Trials Implementation and Monitoring
- Investigational Site Management
- Data Verification and Accuracy
- Team Leadership and Mentoring
- Regulatory Compliance (ICH-GCP, GLP, GMP)
- Strategic Planning and Coordination
- Multilingual Communication
- Systems Proficiency (CTMS, EDC, eTMF, IXRS, IRT)
- Data management proficiency
- Coordinating site operations
- Informed consent process
- Adverse event reporting
- Medical terminology fluency
- Investigator relations
- Regulatory compliance
- ICH-gCP guidelines
Certification
- ICH GCP E6 Training Certificate, 01/2012
- ICH GCP E6 Training Certificate, 10/2014
- Outlook: Efficient Email Management, 09/2024
- The Step-by-Step Guide to Building your Thought Leadership on LinkedIn, 09/2024
- Collaboration Principles and Process, 10/2021
- Learning Excel 2019, 10/2021
- How to Set Goals When Everything Feels Like a Priority, 10/2021
- 15 Secrets Successful People Know about Time Management (getAbstract Summary), 10/2021
- Excel: PivotTables for Beginners, 09/2024
- ICH GCP E6 Training Certificate, 12/2024
Languages
English
Russian
Ukrainian
Polish
Personal Information
Nationality: Ukrainian
Consent
I consent to the processing of my personal data for the purpose of recruitment for the position to which I am applying.
Timeline
Senior Clinical Research Associate
ICON, Formerly PRA Health Sciences
04.2021 - Current
Clinical Research Associate 3
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
09.2019 - 03.2021
Clinical Research Associate 2
COVANCE CLINICAL DEVELOPMENT SERVICES CRO,
02.2016 - 09.2019
Clinical Research Associate 1
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
06.2015 - 01.2016
Trainee Clinical Research Associate
COVANCE CLINICAL DEVELOPMENT SERVICES CRO
08.2014 - 06.2015
Doctor Assistant -
Communal Institution Nizhyn medical college
General pathologist -
National Medical University named after A.A. Bogomolets
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