Sokol Shala

Experienced clinical research professional with a strong background in managing and delivering complex clinical trials across multiple specialties. Proven expertise in ensuring regulatory compliance, overseeing study conduct, and facilitating successful site initiation and monitoring visits. Skilled in supporting researchers with funding applications, regulatory submissions and operational troubleshooting.

Demonstrated leadership in managing research teams, fostering collaboration with internal departments and external stakeholders and driving trial success. Adept at balancing strategic oversight with hands-on involvement in patient care, data management and research governance.

CRF Quality Assurance Manager - Kings College Hospital NHS Foundation Trust

(2025-01)

• Leading end-to-end quality management systems for the Clinical Research Facility, ensuring continuous inspection readiness and compliance with MHRA, ICH-GCP and Trust requirements.
• Regulatory liaison for MHRA inspections, leading inspection strategy, hosting inspectors, managing findings and delivering CAPAs.
• Developing and governing a comprehensive SOP document control framework, aligning CRF working practices with regulatory, ethical and legislative standards.
• Overseeing governance systems for IMP accountability, adverse event reporting, data protection and biological sample handling, ensuring subject safety and regulatory integrity across all trial phases.
• Leading inspections and internal audits, providing senior management with actionable assurance reports and driving continuous quality improvement.
• Taking a leadership role in supervising and supporting junior staff within the team, helping them develop skills and contribute effectively to the team

Clinical Trial Manager – Sarcoma - The Royal Marsden NHS Foundation Trust

(2025-01)

• Establishing and maintaining channels of communication within the team, associated departments and relevant organisations including non-commercial bodies and funders. Contributing to design and validation of databases for each study. Ensuring trial specific monitoring plans are created and adhered to.
• Leading on clinical trial design, protocol development and funding applications. Monitoring of activity and conduct of designated clinical trials. Planning and performing site initiation visits.
• Supporting and actively engaging in the creation of the documentation required for each study, as well as amendments to study documentation and submissions or reporting to regulatory authorities.
• Ensuring clinical trials are conducted in accordance with regulatory requirements including: Medicines for Human Use Regulations, Research Governance Framework for Health and Social Care & Human Tissue Act

Research Facilitator - Oncology - National Institute for Health and Care Research

(2023-01 - 2024-12)

• Managing a portfolio of multiple research projects within Cancer, Cardiovascular, Reproductive Health and Paediatric specialties, ensuring that studies are set up in a timely manner and in line with organizational objectives.
• Supporting researchers by providing advice on AcoRD cost attribution, facilitating review of NIHR Industry Costing, advising on portfolio eligibility processes, study setup, recruitment and data reporting requirements.
• Monitoring delivery of research projects to ensure that studies recruit to time and target, identifying barriers and facilitating resolution of operational issues
• Providing regulatory advice and assisting with REC/HRA and Trust R&D applications for researchers and sponsors.

Senior Clinical Research Practitioner – Oncology - Imperial College Healthcare NHS Trust

(2022-01 - 2023-12)

• Working within relevant regulations ensuring study protocols are adhered to and keeping trial site files updated in accordance with sponsor guidelines.
• The lead and point of contact on multiple studies, liaising with principal investigators, study sponsors and clinical research associates.
• Determining site and study feasibility of studies, organizing site investigation visits and monitoring visits ensuring patient safety and correct clinical procedures.

PGDip - Physician Associate - St George's, University of London (2017-01 - 2019-12)

MRes - Human Genetics - St George's, University of London (2015-01 - 2015-12)

BSc (Hons) - Biomedical Science - St George's, University of London (2011-01 - 2014-12)