Experience

PSI CRO UK LIMITED

• Clincal Trial Lead

  • Jun 2019 - Present

• Senior Clincal Research Associate

  • Jan 2015 - May 2019

  I am an experienced clinical research professional with over 9 years experience in the industry. I have experience in all 4 phases and across all stages of research, from site selection to site close out as both a CRA and clinical lead. I have a broad range of therapeutic experience including oncology, respiratory, CNS, women's health, paediatrics and cardiovascular.



Sumpter Clinical Research Solutions Ltd

• Maternity Leave

  • Oct 2013 - Oct 2014

  I am currently on maternity leave but I am looking to return to work immediately as a part-time contract CRA based in the North West of England

• Freelance Clinical Research Associate

  • Jul 2012 - Oct 2013

  Field-based contract position with ICON Plc. as the CRA on a Phase I clinical trial. Responsibilities included key document collection, contribution to Ethics Submission process, Site Initiation and monitoring.Field-based contract position with PSI as the CRA on a Phase III Oncology study. Responsibilities included monitoring and close out of sites. I also worked on a Phase III Paediatric Study in Hunter's Syndrome and was involved in site Initiation and monitoring of the sites. In addition, I was praised for the high standard of my monitoring visit reports and was invited into the office to provide training to the CRA's on how to write a good monitoring visit report.



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Operations Leader

  • Jan 2008 - Jul 2012

  As Clinical Operations Leader, I coordinate clinical activities on international multi centre trials and I am responsible for the management of all clinical deliverables of the project in accordance with the study budget and timelines. Some areas of current responsibilities as COL include: contact with client, running CRA teleconferences, creating tools and monitoring plans and central file maintenance. I have also actively participated in Investigator Meetings. As Clinical Operations Leader, I coordinate clinical activities on international multi centre trials and I am responsible for the management of all clinical deliverables of the project in accordance with the study budget and timelines. Some areas of current responsibilities as COL include: contact with client, running CRA teleconferences, creating tools and monitoring plans and central file maintenance. I have also actively participated in Investigator Meetings.



Organon Laboratories

• India
• Appliances, Electrical, and Electronics Manufacturing

• Clinical Research associate

  • Feb 2005 - Jan 2008

  The main responsibilities included monitoring clinical trials in accordance with ICH-GCP Guidelines, Monitoring Guidelines and applicable SOP’s. This included site selection, preparing documentation for R&D, ethics and regulatory submission and approvals, initiating sites, site monitoring, source data verification, drug accountability, ongoing site management, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, data collection, following up and solving data queries and performing site close-out visits.