Farjana Haque

• Developed effective strategies by analysing data from various departmental reports.
• Established an effective communication system to ensure smooth workflow across the team
• To establish and maintain effective management systems for the trial
  • To provide a central point of communication between global teams
  • To liaise with all collaborating organisations and individuals as required ensuring the smooth running of the trial and ensure study launch, conduct and closeout according to the project milestones.
  • Secure all necessary regulatory and ethics approvals for the trial and participating sites both locally and internationally
  • Co-ordinate the design, printing and distribution of trial documentation
  • Develop trial specific documentation and Standard Operating procedures (SOPs) and ensure this is implemented and kept up to date.
  • Ensure sites have appropriate training and maintain necessary records.
  • Monitor study budged and resources
  • Provide updates on the progress of the trial to trial committees.
  • Prepare under the guidance of the Project Manager, the trial specifications for the database
  • Supervise the data collection, cleaning and validation, including querying and chasing missing data in a timely manner.
  • To provide ongoing monitoring (SIV, on – site and close out)
  • Represent the trial at conferences, meetings and internal unit meetings as appropriate.

•Assisting with the coordination of a large multicentre cluster randomised controlled trial
•Coordinating site and participant recruitment & enrolment
•Ensuring adherence to trial protocol at participating sites
•Assisting with source data verification and data cleaning on CRF for data analysis

• Assisting the CI with the set-up of an NIHR funded ophthalmology study across over 40 sites
• Ensuring all necessary approvals were in place, recruiting sites were initiated and staff were appropriately trained
• Ensuring participant recruitment met target
• Assisting with the design and testing of the trial database system for data entry
• Day-to -day management of the trial in close communication with chief investigator, TMG, TSC and DMC
• Communicating the underlying medical and scientific rationale of the trial to a wide professional audience
• Responsible for answering queries and resolving any technical or administrative barriers to participants

• Responsible for the provision of full administrative service to the Lung tumour research team. I had a pivotal role in coordinating and conducting in-house, commercial and non-commercial national and international phase II and III clinical trials in accordance with EU Trials
  Directive. I lead on a portfolio of trials participating in patient identification and recruitment.

• Liaised with the clinical team to organise and ensure that trial specific investigations were undertaken according to the current protocol and obtained the results
• Liaised with sponsor and monitors for keeping up to date in clinical trial timelines, recruitments, schedules, amendments and data related issues
• Accurately recorded observations required per protocol with the aid of an electronic blood pressure monitor and digital thermometer
• Ensured the confidentiality of verbal, written and computerised information
• Liaised with trial pharmacy to co-ordinate the availability and dispensing of trial drugs as required
• Processed biological samples according to the trial-specific lab manual and organised the storage and shipment of protocol specific
  samples
• Lead on stock control and ordering of consumables
• Completed case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient’s medical notes and trial file were transcribed accurately with attention to detail
• Prepared the relevant documents required when submitting trial protocols and paperwork for regulatory review and approval
• Assisted with the completion of submissions to Ethics Committees and the Research & Development Department
• Created and maintained the file of current protocols, patient information sheets and Informed Consent Form
• Responsible for the maintenance of the Investigator Site Files. Assisted in the creation and maintenance of good office systems for the smooth running of the service
• Formulated and maintained the databases for clinical trials
• Collated, manipulated and extracted data. Compiled reports for the Clinical lead, Clinical Trials Manager and both commercial and non-commercial sponsors
• Being a dedicated archivist for the team
• Dealt with data queries in a timely and efficient manner
• Formulated trial-specific EXCEL worksheets for each trial
• Organised and prepared documentation for audit and monitoring visits
• Provided information to allow invoices to be raised for payments where appropriate
• Arranged, attending and recorded minutes for research and other relevant departmental meeting
• Actively seeking to develop the role to take account of changing requirements of the service
• Attended national and international Investigator Meetings and conferences
• Disseminated research by assisted in the preparation of posters/research papers for meetings, conferences and publications

• Assisted in the conduct of Phase I studies across a range of therapeutic areas
• Screening healthy volunteers and patients per protocol
• Reviewing clinical trial protocols and commented on the feasibility. Reviewed and input into the design of the screening section of Case Record Forms (CRFs)
• Ensuring sufficient appointments were made to meet the needs of planned/expected screening targets
• Preparing clinical equipment and areas for screening activities
  Preparing study documentation
• Ensuring database records were kept up-to-date: completing and tracking logs to ensure that screening information was visible for other departments to view
• Performing clinical investigations on subjects (physiological measurements including ECG’s, Blood Pressure measurement, Lung Function test ,Holter monitoring, venepuncture)
• Collecting and processing urine, breath alcohol and other specimens which included simple laboratory procedures
• Requesting clinical pathology investigations and reviewing results in co-operation with Research Physicians, arranging repeat samples as required
• Sending GP reports and chasing outstanding reports to ensure all data is collected prior to a volunteer’s inclusion
• Communicating with volunteers to ensure that they were kept updated on the progress between screening and inclusion
• Developing and overseeing systems to ensure compliance with the Data Protection Act
• Completing CRF’s and capturing trial related data
• Collating CRF’s, laboratory and other results and performed quality control checks to ensure they were complete and ready for review and approval by Research Physicians
• Maintaining effective communication with the project managers, nurses and physicians
• Liaising with Line Manger regarding potential efficiencies and improvements within screening/recruitment
• Contributing to the maintenance of excellent relationship with the members of the public and volunteers to ensure that the organisation was always held in the highest regard.