Lisa Perry Email & Phone Number

Fareham, Gb

United Kingdom

Home Based

- Ensure successful delivery of initial regulatory and ethics submissions as well as maintenance activities for assigned studies in the United Kingdom and Ireland according to applicable regulations, SOPs and work instructions. This includes experience in the following study types: gene therapy, rare disease, oncology, studies with radiation, umbrella studies, pharmacy assurance, neuroscience, - Prepare, collect, and review site regulatory documents to achieve site activation according to mutually agreed timelines. Delegate tasks if needed and manage clinical teams to drive site activation. Assess barriers to meeting milestones and escalate/problem solve solutions as appropriate. - Act as country intelligence coordinator for bid defense queries, study teams and curate Regulatory information database. - Completed submission request to re-start study submission one week ahead of schedule and UK was subsequently first country globally to achieve regulatory and ethics approval - Review ICFs, essential document and submission packages for colleagues - Provide support and training to junior team members. Created and delivered essential document and clinical trial application training materials to CRA school cohorts. - Took part in successful initiative to increase regulatory compliance review pass rate metrics.

- Joined a CRO with less than 20 employees to gain a wide range of experience- In addition to standard CRA II tasks as described below:- Worked on a COVID-19 study and a medical device study, collaborating closely with clients and project managers. - Updated a protocol and created SIV training slides- Gained experience of monitoring remotely and helped to develop a monitoring plan

Home/Field Based

Perform assigned activities within UK and/or Ireland that lead to start-up of investigative sites in all phases of clinical trials. Responsible for delivery and specialist knowledge in the following functional areas: ethics and regulatory submissions, and reviews of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. Depending on sponsor requirements may act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). May directly interact with Customers when requirements are received from RA or other local regulatory party. Provide support as the Country Start-Up Advisor (CSA). Perform quality reviews on colleagues' submission packages to ensure quality is delivered right first time.

Home/Field Based

– Single Sponsor- Worked on three ovarian cancer and two juvenile idiopathic arthritis clinical trials simultaneously- Performed pre-trial assessment, site initiation, routine monitoring and close-out visits for sites in the required timelines in the United Kingdom and Ireland- Supported new employees in using clinical trial systems and sponsor-specific processes- Worked with study team and sites to achieve database lock 3 days ahead of schedule- Proactive in offering to perform, and performed, additional days on-site as lead monitor or co-monitor for program of studies with SDV backlog- Flexible and versatile to ad hoc requests from line management- Created, maintained and developed excellent relationships with sites- Supported audit and inspection activities during MHRA inspection. Contributed to QA processes associatedand acted on resolution activities as requested- Successfully promoted to role within two years of starting clinical trials career and first CRAin Business Unit to be promoted from Monitoring Foundations program

Home/Field Based

Home/Field Based

– Single Sponsor- Worked on two ovarian cancer, one head and neck and two rheumatoid arthritis clinical trials simultaneously- Closely collaborated with internal and external clients to achieve interim analysis and database lock on schedule- Was personally requested to work on a study permanently after performing SWAT CRA role- Performed six close-out visits within tight study deadline

Maidenhead, Berkshire, United Kingdom

- Successfully completed monitoring foundations training program and assigned to key client single sponsor- Proactive in completion of assignments and organising facilities as appropriate

South Central England

• Ran own successful business as a personal tutor to students, on a one-to-one basis in Science and Mathematics around South Central England• Students ranged from Key Stage 2 to degree level• Initial steps started with finding expectations from the parents and the student• Analyse student performance with past papers and activities• Enhance student in weak areas with knowledge development, exam and revision techniques• Am very flexible and work with parents and students to ensure all parties are kept informed, in agreement and happy• Last academic year realised my aim to increase client base to a full-time basis

• Research, design and optimize experiments/assays to answer scientific questions• Organised experiments to manage time effectively• Collaborated with other departments such as Goods-in, Procurement, Safety, Microscopy and External Researchers or Clinicians• Wrote SOPs for lab procedures adhering to GLP• Produced risk assessments as required by university protocol• Attended and presented at the annual national conference for my field of research, Translation UK from 2010 to 2013.• Attended and presented at the biannual international conference, EMBO Conference Series: Protein Synthesis and Translational Control 2013• Achievements:o Awarded EMBL Corporate Partnership Registration Fee Fellowshipo Awarded Biochemical Society Travel Grant.• Publications:o http://www.ncbi.nlm.nih.gov/pubmed/25597744o http://www.ncbi.nlm.nih.gov/pubmed/24091728

• Present to undergraduate students the scientific theory behind, and how to perform, an experiment• Supervise students to ensure GLP was followed• Used initiative to solve problems as they arose and to ensure a positive student experience• Assess completed reports and record marks onto an online database• Presented to potential students and parents at open days• Worked as a call handler at temporary call centre set up for UCAS clearing in 2014

Bachelor Of Science (Hons), Biochemistry, 1St Class Degree

Activities and Societies: Student Staff Liaison Committee• Voted Chairperson of the student staff liaison committee 2007 – 2009 •.

Education record