Senior CRA @ Senior cra for phase 2/3 oncology trials. From October 2014 to Present (1 year 3 months) freelance CRA/DM @ Site Initiation Visits- set up and conduct
Creation of Investigator Site File templates/documents
• Delegation log
• screening/ recruitment log
• Standard Operating Procedures
• Case Report Forms & source data forms
• SAE /pregnancy report forms
Perform on site monitoring visits
• Review of site file
• Source data verification
• Raise Data Queries
• IMP monitoring/ Drug Accountability checks
• Informed Consent verification
Completion and QC of monitoring reports
Identification of protocol or GCP violations/deviations
Preparation for MHRA inspection
Disease Areas of expertise:
Oncology (6 years)
Neurology (5 years)
Rheumatology (4 years)
Haematology (4 years)
Specialised Rehabilitation (4 years)
Devices (5 years)
Investigational Medicinal Products (8 years) From March 2006 to October 2014 (8 years 8 months) Research Coordinator @ Governance Coordination for 5 directorates (15 directorates across Trust)
• complete / submit studies for Ethical Committee Opinion
• complete/submit studies for Competent Authority (MHRA) opinion
• Apply for NIHR portfolio adoption
• negotiate study agreements/ contracts
• Identify and agree funding/ costs for study
• facilitate Data Protection/ Caldecott agreement
• Ensure Human Tissue Requirements are met –including Material Transfer Agreements in place
• Ensure ARSAC/IRMER arrangements in place
• Issue NHS Permission on behalf of R&D Director (for all Trust studies)
Perform NIHR study wide review on behalf of CLRN
Member of Research Executive for 3 directorates
Monitoring & Audit advisor to lead
• Assist with developing template documents
• Perform monitoring & audit visits
• Complete monitoring & audit reports including action items
Department lead and advisor for Pharmaco -vigilance
• Develop Standard Operating Procedure
• Perform training
• Create SAE form templates
• Roll out SAE reporting procedure across Trust
• Create/ use and QC SAE database
Department Lead and advisor for Source data recording
• Developed Trust-wide procedure for recording in source data (patient notes)
• Provide template forms to streamline SDV review
• Work with Informatics to ensure research requirements are met with Electronic patient record.
Department lead for Research Standard Operating Procedures
• Create template SOP for use by all Researchers
• Develop SOPS for lead areas
• Manage full suite of R&D SOPs – release /review/archive
• Review & approve study specific SOPs
• Review & approve support service/ research teams SOPs From March 2003 to October 2014 (11 years 8 months) Data manager @ From 2000 to 2003 (3 years)
BSc (Hons), Applied Biology @ De Montfort UniveristyMyers Grove School Anna Leesley is skilled in: Clinical Research, Public Health, Epidemiology, Healthcare, Clinical Trials, Hospitals, Medicine, Healthcare Management, Qualitative Research, Healthcare Information Technology, Research, Global Health, Oncology, Infectious Diseases, Haematology