Client portfolio:
Bristol Myers Squibb
May 2011- Present
Position: Senior Clinical Site monitor
Responsibilities: Monitoring across 4 oncology protocols, managing sites in the south East of England. Also involved in pre-selection of sites for CNS andd HIV studies. Working to ICH GCP, company SOPs, to local ethics and regulatory guidelines.
Attended Investigator meetings.
Novo Nordisk limited
November 2010-May 2011
Position: Senior clinical Site monitor
Responsibilities: Monitoring phase 3 diabetes trials in the central region of the UK to include the north west of England and Scotland. Helped set up obesity trias in the UK, was involved in site selection and site initiation of these trials.
Conducted Recruitment stategy meetings with sites prior to site initiations.
Attended Investigator meetings.
I3 Research
February 2007- November 2010.
Position: Lead CRA (Clinical Team Leader)
Responsibilities: Managed a group of 10 site monitors, 16 sites,over 6 countries internationally across Europe ad South Africa in a programme which consisted of 4 protocols.
- Providing Clinical support to site Monitors who reported to me for the protocols.
- Dealing with day to day queries regarding running of the protocols to include drug shipment, IVRS issues, and laboratory shipments.
- Liaising with External Vendors.
- Involved in the preparation for an MHRA GCP inspection.
- Input in the writing of monitoring plans.
- Coordinating the approval of certain equipment required by sites.
- reviewing and approving drug release packs prior to site being activated by the sponsor.
- Chairing regular teleconferences with the CRA team.
- Reviewing and approving visit reports to include Site selection, initiation, monitoring, and close-out vist reports.
- Helping CRAs to meet site targets for screening and randomising patients.
- Overseeing and ensuring the appropriate capture of data in the eClinical database.
- Ensuring proper recording of protocol deviations and reporting of violations.
- Liaising wth regulatory department and CRAs for the submission of protocol amendments to ethics and regulatory per country requirements.
- liaising with contracts department to ensure timely execution of site contracts to streamline the site set up and initiation process.
- Ensuring appropriate completion of the electronic CRF.
- Conducting accompanied visits with the CRAs.
- Performing motivational site visits.
As an acting Project mnager:
- Producing weekly study status reports.
- Attending weekly sponsor teleconferences.
- Reviewing site invoices for approval.
- Liaising with the sponsor to resolve site issues.
- Dealing directly with sponsor requests and providing timely delivery of resolution.
- Hosting Sponsor Audits.
Quintiles, Bracknell
May 2005- February 2007
Position: Clinical Research Associate (CRA)
Experience and responsibilities as a site monitor:
Study start up:
- Performing feasibility
- Preparations for ethics, R&D, and PCT approvals, collecting essential documents.
- Drawing Financial contracts.
- Selecting study sites, locating and assessing sites resources for suitability.
- Providing training to principal investigators and study team on protocol and study conduct. Ensuring investigators have ICH GCP training.
- Setting up study centres- ensuring all sites are fully equipped with the required trial materials, protocols, IDB, Site Files, CRFs, Investigational products.
- Initiating projects at site.
Interim Monitoring:
- Visiting sites periodically as per study monitoring guideline schedules, to monitor data and patient safety.
- Source data verification.
- reviewing protocol deviations and violations.
- Performing Interim study drug accountability.
- Collecting CRF pages for those studies not using eCRFs.
- Writing visit report within designated time.
- Hosting sponsor audits and receiving positive feedback.
Site Close-out activities.
- Closing study sites.
- Ensuring all required documents are maintained.
- Briefing investigator on their responsibility for archiving and informing them of the possibility of future audits.
- Performing final study drug accountability and reconcilliation as appropriate.
- Arranging for removal of equipment provided.
- Following queries issued by data management to resolution.
Other responsibilities
- Working to and ensuring deadlines are adhered to.
- Working to company and sponsor company standard operating procedures.
- Training of new CRAs via accompanied visits and conducting observation visits.
Quintiles, Guys Drug Research Unit.
From June 2003- May 2005.
Position: Clinical Poject associate.
Responsibilities: Woked in the pathology laboratory of the phase 1 unit, involved in setting up projects logistically for the laboratory. Worked closely with internal and external clients, managing project resources for the laboratory. Worked in a fast pace environment due to the nature of phase 1 trials, short and intense, this allowed me to work on several different company products, and was a great introduction to the world of clinical research.
From June 2002- June 2003- 1 year university sandwich placement with Quintiles as a laboratory assistant.
