Azrah Bashir

• Lead on start-up activities for multi-part phase I and II clinical studies in partnership with international sponsors, ensuring adherence to timelines, budgets, and regulatory requirements
• Consulted on clinical trials regulatory submissions and mid study changes to the protocol using previous company experiences to yield favourable opinions from the REC and MHRA
• Used milestone trackers, in-house project management tools and software such as Monday.com to track study progress
• Acted as the primary liaison between internal teams, sponsors, and regulatory bodies, effectively managing stakeholder expectations
• End to end management of trials including oversight of clinical conduct, pharmacy manufacturing procedures and Lab processes, in line with GCP, GMP and GLP guidelines
• Effectively communicated mid trial changes and requests from sponsors to their appropriate delegations, ensuring the conduct of the trial met expectations and investigational needs of the protocol

• Managed the development of SDTM annotations for datasets in electronic case report forms, using SAS programming to create lab transfer files for interim safety analysis, ensuring project timelines and quality standards were adhered to
• Collaborated in a specialised team in the programming, piloting, and company-wide distribution of a novel site automation system, aiding in streamlining project workflows to enhance efficiency

Assistant Clinical Project Manager (Jan 2023- Jan 2024) Data Manager (Jan 2022 - Jan 2023) Recruitment and Screening Associate (Jan 2021 - Jan 2022) Clinical Trials Associate (Sep 2019 - Jan 2021)

Completed a 4.5 year degree apprenticeship with the University of Kent, rotating yearly to a new department within the organisation.

• Prepared, maintained, and archived essential trial documents for sponsor eTMF systems to ensure audit readiness. Fostered seamless communication and collaboration among internal departments including the ward, pharmacy, laboratory, and physicians to effectively execute trial protocols.
• Conducted quality control reviews of key trial documentation to uphold compliance with GCP and regulatory guidelines. Collaborated in the creation and review of protocols and information and consent forms.
• Performed data reviews to ensure quality controlled source data. Produced comprehensive tables, figures, and listings to be included in clinical study reports at study closeout, contributing to expected project deliverables.
• Evaluated volunteers' eligibility to participate in clinical trials in adherence to ICH GCP and confidentiality guidelines to maintain ethical integrity in project execution.
• Performed safety evaluations in collaboration with physicians on volunteers at screening visits, by recording electrocardiograms, vital signs, and obtaining biological samples in line with protocol requirements.
• Co-ordinated the recruitment process of multiple trials, implementing various diverse recruitment strategies to maintain high efficacy in volunteer enrolment.
• Acted as the primary ward contact for multiple phase 1 and 2 first in human neurological, respiratory, and cardiac drug studies.
• Maintained paper and electronic trial master files, investigator site files, and other trial documentation throughout studies to maintain audit readiness and comprehensive access to all trial related documents.
• Undertook additional roles following promotion to senior associate, such as electroencephalogram operator, staff trainer in trial specific procedures such as ERT Holter devices, quality control coordinator, and mentor to new staff members to support project continuity.

• Operated OCT and digital retinal photography equipment and learnt to identify and interpret various retinal pathologies.
• Worked in the glazing lab to glaze single, bifocal, and varifocal glasses, as well as dispensing NHS forms.
• Carried out contact lens consultations for patients and trained work experience students on placement programs.