Ayaz Alam

Presently, I am working with LifeScan Scotland as a Clinical Research Associate for medical devices. Experience in a wide range of commercial & non-commercial studies and regulatory governance. An accomplished and fluent communicator with strong investigation, problem-solving, and decision-making skills, combined with a pragmatic approach and sound research acumen. 

Professional Experience 

Clinical Research Associate (CRA II), LifeScan Scotland ltd, Inverness

October 2021 -present, 

Protocol: OneTouch VerioVue Enhancements, Arterial & Neonate Study

• Write key clinical documents e.g., Protocol, Clinical Plan, Critical Areas to Test (CATT) documents.
• Designing CRF, Patient Information sheet, patient Consent Form
• Perform Site qualification Activities of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials.
• Manage NIHR Central Portfolio Management System (CPMS), Interactive Costing Tool (iCT) for new studies.
• Chair Clinical Readiness Review meetings, Site Initiation Visit (SIV) meetings, provide training to study staff.
• Perform site activity update meetings with junior CRA and study staff
• Responsible for Data Base Development, user requirements specification review, User acceptance testing (UAT), validation Summary Report
• Represent core meeting for new the project

Clinical Data Associate, Sarah Cannon Research Institute, London, 

August 2021 – September 2021

• Making sure that the data and results are tracked timely in the eTMF and is all time ready to be inspected
• Assisting in data queries
• Compiling subjects specific file and make sure all the documents are filed as per GCP
• Liaise with research team and sponsors to update all related queries.

CRA I, PRA Health science, South Oak Way, Reading, Berkshire, 

May 2021-july 2021

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines 
• Reviews and verifies the accuracy of clinical trial data collected, either onsite or remotely
• Provides regular site status information to team members, trial management, and updates trial management tools
• Completes monitoring activity documents as required by gsk SOPs or other contractual obligations
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues, escalates site and trial-related issues per gsk SOPs, until identified issues are resolved or closed

Clinical Trials Monitor/Senior Trial set-up Technician, Royal London Hospital, Bart’s Heath NHS July 2018 – 30/04/2021.       

Protocols:

Recovery; Randomised Evaluation of COVID-19 Therapy

Remap-Cap; Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia

GS-US-540-5821 (remdesivir) Expanded Access Treatment

• Site qualification, risk assessment, feasibility assessment, study set-up, site initiation, close-out and archiving
• Provide training and resources for better adherence to the protocol and SOP, and verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
• Review, complete, and submit corrective and Preventive Action (CAPA) to Joint Research management office (JRMO) within the set time frame.
• Make sure the sites are ready for governance inspections.

 Clinical Trial Setup - Duties 

Protocols:

RECOVERY (Covid-19 study), ARCADIA, Phase ii (renal), ARMOR Phase ii (Hepatology), Ascend Waiha, M14- 430(Gastro), MESSINA (DB+OL treatment), Contrast-2, (Phase-ii, Musculoskeletal), AZTEC, (Double-blind, randomised placebo-controlled, Paediatrics), PRN1008-012 (Phase- 3, Dermatology), DESTINY PWS(Paediatrics), PHOSPHO-Tof RA(OL/rheumatology) etc.                         

• Clinical trial set up, procedure writing, amendments, monitoring reports, closed out, archiving.     
• Managing IVRS for IMP, patient randomisation, electronic accountability. 
• Final dispensing check for Investigation Medicinal Product. 
• Utilise Information Governance guidance for the handling of sensitive patient data 
• Work collaboratively with the Principal Investigator, Research Lead Nurse and the existing clinical trials team, multi-disciplinary teams and Allied Health Professionals to assist in developing clinical trials services. 
• Liaise with members of the multi-disciplinary team i.e. Pharmacists, research nurse, CRA to ensure safe and smooth running of trials 
• Ensure that all research governance approvals (both locally and externally) are in place prior to commencing the trial. 
• Providing training for new study, participating/leading site and departmental meetings.  

 Senior Medicine Management Technician, Queens Hospital NHS, London, UK 

Aug 2016 to Jan 2017           

• Provide technical support to the dispensary, including the labelling and dispensing of inpatient requests, outpatient and discharge prescriptions, accredited Checking

Pharmacy assistant Manager, Day Lewis Pharmacy, Oct 2008 to Jul 2016 

Duties  

Manage and maintain everyday pharmacy activities. Final dispensing checking, managing staff, managing inventory, and preparing for governance inspection. Maintain and implement procedures, legislation, or national guidelines.

MSc in Pharmacology, Glasgow Caledonian University, Glasgow, Scotland, (UK), first class, Sep2007-Sep2008