Experience

Cancer Trials Ireland

• Ireland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Jul 2019 - Present

  Primary Responsibilities:• Ensuring that all clinical trials under my supervision are conducted, recorded and reported in accordance with the study protocol, applicable SOPs and according to the applicable regulatory requirements• Developing and maintaining strong working relationships with participating hospital sites, collaborative group and pharmaceutical companies• Coordinating protocol development by working with Principal Investigators, other Cancer Trials Ireland staff and statistics and data management• Contributing to CRF development and design when required• Ensuring regulatory and ethics compliance for studies under my supervision.• Ensuring budget agreements and contracts or roles and responsibilities are in place• Overseeing the process of study initiations and ongoing education• Reviewing and signing off monitoring reports prepared by CRAs and identifying issues requiring action and managing the process of resolution of these problems for studies under my supervision• Providing support and training to Cancer Trials Ireland staff• Confirming the necessary processes are in place for study drug supply for studies• Communicating regularly with key research personnel at study sites/ industry to review the progress of studies• Trouble shooting study related issues in a broad range of areas on a day to day basis• Manage study close out requirements• Managing the study budget and associated financial activities when applicable• Contributing to SOP development when required

• Clinical Research Associate

  • Jan 2014 - Jun 2019

  Primary Responsibilities• Perform activities according to ICORG and/or Sponsor SOPs (if applicable).• Collect and maintain essential documents as required by ICH-GCP, ICORG and/or Sponsor SOPs and regulatory requirements/ethics committees.• Assist in preparation and review of study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others).• Assist with the preparation of Regulatory Authority and Ethics Committee submissions if required.• Perform study initiation visits.• Perform monitoring visits according to the study monitoring plan in Ireland and overseas if required.• Monitoring and reconciliation of Serious Adverse Events (SAEs).• Tracking of clinical trial activities.• Take all reasonable precautions to ensure patient confidentiality is maintained.• Identification and communication of scientific misconduct.• Perform site close-out visits.• Prepare reports of initiation, monitoring and close-out visits and follow-up on outstanding issues.• Communicate on study issues internally at ICORG and/or with Sponsor (if applicable) and with Investigator and site staff.• Meet regularly with the CPM/CPL to review/update on the status of studies regularly and upon request.• Help organize and attend Investigator meetings if applicable.• Prepare and make presentations as required.• Attend training programs as specified by the Line Manager.• Contribute to preparation for audits and inspections as required.• Perform other tasks as specified by CPM/Line Manager/CPL.

• Clinical Trials Administrator

  • Jan 2011 - Jan 2014

  Responsibilities:• Preparation and maintenance of Trial Master and site Files• Assist with collection of essential documents as specified by CRA/CPM• CRF (Case Report Form) tracking and logging of CRF pages• Shipping CRF pages to Data Management (DM)• Ordering of clinical trial supplies as specified by CRA/CPM• Contribute to the preparation and submission of Regulatory dossiers• Contribute to the preparation and submission of applications to ethics committees• Responsible for main reception phone• Co-ordinate queries and direct issues to appropriate clinical research personnel• Assisting in administration of training courses• Update and upkeep of ICORG membership details• Participate in out of hours meetings from time to time• To perform other tasks as specified by CPM/CEO



ALcontrol Laboratories

• Laboratory Analyst

  • Feb 2008 - Apr 2009

  Responsibilities: Prepare and analyse water and soil samples using different analytical techniques – spectrophotometric, gravimetric methods, titration, carbon and sulphur analyser; GC; HPLC; maintenance of equipment, troubleshooting; use of LIMS, IFS; maintain all work records and AQC charts; calibration of pipettes and thermometers, development of methods. Responsibilities: Prepare and analyse water and soil samples using different analytical techniques – spectrophotometric, gravimetric methods, titration, carbon and sulphur analyser; GC; HPLC; maintenance of equipment, troubleshooting; use of LIMS, IFS; maintain all work records and AQC charts; calibration of pipettes and thermometers, development of methods.



Faculty of Chemistry, Vilnius University

• Lecturer / Research fellow

  • Dec 2001 - Jun 2007

  Responsibilities: Organize and conduct lectures and seminars in Adsorption, Electrochemical Kinetics and Electrometry, organize demonstrations, seminars and laboratory works of Physical Chemistry and Colloidal Chemistry; supervise for final year undergraduate and graduate university students in their thesis work, conduct examinations. Conduct research work, manage scientific projects and supervise postgraduate student work. Responsibilities: Organize and conduct lectures and seminars in Adsorption, Electrochemical Kinetics and Electrometry, organize demonstrations, seminars and laboratory works of Physical Chemistry and Colloidal Chemistry; supervise for final year undergraduate and graduate university students in their thesis work, conduct examinations. Conduct research work, manage scientific projects and supervise postgraduate student work.