Марія

Mariia Rudyk
Clinical Trial Assistant | Study Start-up | Junior CRA
Location: Kyiv, Ukraine | Phone: [open contact info](look above in the "contact info" section) | Email: [open contact info](look above in the "contact info" section)
Telegram: mia_ryk | LinkedIn: [open contact info](look above in the "contact info" section)
PROFESSIONAL SUMMARY
Clinical Research Coordinator with 2 years of site experience across 25 clinical trials (up to 8 at a time), from study start-up to monitoring visits. Grew with a start-up research site as its first and later senior coordinator: built documentation templates and internal audits, trained 5 new coordinators and worked daily in 20+ sponsor and vendor systems. ICH-GCP E6 (R3) certified, with 2 years of medical university training. Seeking a Clinical Trial Assistant, Study Start-up or junior CRA role at a CRO or sponsor.
PROFESSIONAL EXPERIENCE
Clinical Research Coordinator | FutureMeds Ukraine (Medical Center “Oberig”)
August 2024 – July 2026
Joined a 4-person start-up research site as office manager and became its first coordinator. As the site grew to ~25 active studies and 11 staff, I acted as senior coordinator and operations support for site leadership, then took over studies left without a coordinator.
• Primary coordinator for up to 8 active clinical trials at a time, plus start-up and backup support on several others (25 in total)
• Ran studies end to end: site-level start-up (protocol review, essential documents, investigator access, equipment, delegation of duties with the PI), presenting site infrastructure at SIVs, and close-out of 3 studies (final documentation review, IP and equipment return, archiving)
• Created documentation templates and ran internal documentation audits across all site studies
• Site contact for CRAs: hosted monitoring visits, resolved eCRF queries and technical issues; handled communication with sponsors, CROs and vendors (patient travel and accommodation)
• Worked across 5 EDC, 6 IRT, 4 eCOA and 5 central lab platforms: data entry, IP dispensing and accountability, eCOA device set-up and reports, lab kits ordering and lab results monitoring
• Maintained RealTime CTMS (subject visits and procedures for sponsor invoicing, visit planning, recruitment metrics). Calculated investigator payments for partner-clinic physicians
• Took over studies after other coordinators left, audited them and closed documentation gaps. Initiated a per-study handover summary to keep continuity
• Trained 5 new coordinators and onboarded 2 study nurses, coached investigators on study systems, recorded training videos, co-wrote quick-start guides with HR
• Reported weekly on each newcomer’s progress. Screened nursing candidates and joined coordinator interviews
• Introduced ClickUp for staff scheduling and study management
• Co-developed site SOPs with management
Clinic Administrator | Universum Clinic
August 2023 – August 2024
Private clinic serving Ukrainian and international patients. Responsible for daily operations and patient flow.
• Planned surgeries end to end: agreed dates and resources with medical staff, arranged supplies and calculated individual pricing
• Guided patients through each stage of care via reception, phone and CRM
• Monitored medication stock, forecasted needs and reported to the pharmacist
• Trained 4 new administrators for the clinic’s franchise locations
Secretary | OTP Bank (Records Management Department)
June 2021 – September 2021
• Registered and distributed incoming correspondence and dispatched outgoing mail
• Supported the head of the department with daily tasks

SKILLS
Clinical research: ICH-GCP E6(R3), study start-up, monitoring visit support and query resolution, IP accountability, delegation of duties, site SOPs, investigator payments
Clinical systems: EDC: Medidata Rave, Oracle InForm, VeevaVault, Zelta; IRT/IWRS: SignantHealth, Calyx, Suvoda, Cenduit, Endpoint, EliLilly IWRS; eCOA: Clario, YPrime, ClinicalInk, Unify; eISF: Florence, Teckro; CTMS: RealTime; central labs: Labcorp, PPD (Preclarus), Q2 Solutions, Medpace, ICON; imaging: Clario (Bioclinica), Alimentiv, VIDA, Judi AG Mednet; Safety: VeevaVault, Shared Investigator Platform
Coordination: visit planning and scheduling, document management, reporting, quality control, onboarding and training
Tools: Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams, SharePoint), ClickUp, Slack, Zoho Cliq, Lakmus, DocDream, ChatGPT, Claude
Languages: English (Upper-Intermediate, B2), Ukrainian (Native)
EDUCATION
Taras Shevchenko National University of Kyiv – bachelor’s degree, Faculty of Psychology (extramural), 2021 – 2025
Bogomolets National Medical University – Medical Faculty №2, 2019 – 2021 (uncompleted)
CERTIFICATIONS & TRAINING
• ICH Good Clinical Practice E6(R3) (2025)
• BLS (Basic Life Support) Training, Universum Clinic (2024)
• Hillel IT School – “QA Manual” course (2021)