Working as an Independent Contractor in Clinical Research in New Zealand.

Research Manager for Cancer & Blood Research Unit. Managing study coordinators responsible for running a large number of oncology and haematology studies. Responsibility for managing the Oncology Phase I unit at Auckland City Hospital. Mixed number of commercial and investigator-led studies.

• Lead CRA responsibility for several large studies across Asia, from start-up, Ethics submissions and monitoring. • Writing, maintaining and reviewing of all study plans and documents as required per study. Reviewing of all visit reports and follow up of issues• Project Manager for studies across Australia and New Zealand• Responsible for management of study budgets, including negotiation of change orders with client, accountability for utilization and realization of studies… Show more • Lead CRA responsibility for several large studies across Asia, from start-up, Ethics submissions and monitoring. • Writing, maintaining and reviewing of all study plans and documents as required per study. Reviewing of all visit reports and follow up of issues• Project Manager for studies across Australia and New Zealand• Responsible for management of study budgets, including negotiation of change orders with client, accountability for utilization and realization of studies, resourcing of study team and all communication with client• Run internal and client study calls, team training and reporting to clients and Managers• Active participation in CRA training programs, leading several modules and presenting at 2-day oncology training program Show less

• Site management in all stages of clinical trials in phase I to IV oncology studies including breast, prostate, lung, endometrial, brain metastases, colorectal, PNET, CML, MDS and DLBCL.• Experience in monitoring and project management of early phase (phase I and translational medicine) studies• Local project management in Australia and New Zealand for tissue collection study, including set-up and Ethics• Local project management responsibility for phase I, II and III studies… Show more • Site management in all stages of clinical trials in phase I to IV oncology studies including breast, prostate, lung, endometrial, brain metastases, colorectal, PNET, CML, MDS and DLBCL.• Experience in monitoring and project management of early phase (phase I and translational medicine) studies• Local project management in Australia and New Zealand for tissue collection study, including set-up and Ethics• Local project management responsibility for phase I, II and III studies, negotiating with Global team overseas to manage budget, sites and patient allocation and managing local sites and CRAs across Australia and New Zealand• Local Ethics and Regulatory submissions for all studies as applicable• Protocol review to ensure amendments are completed as appropriate to assist with local recruitment• Budget and contract negotiation with sites and Global team to ensure clinical trials are run within budget• Review of SOPs and local compliance requirements, including advising colleagues on local practices• Mentoring of local CRAs within NZ and Australia and local country representative for regional training• Designing and holding site GCP training to ensure compliance with local and global procedures Show less

• Site feasibility, selection, initiation/set-up, ongoing monitoring and site management and close-out activities in the following therapeutic areas:o Oncology – colorectal, breast, prostate and lung cancer, as well as phase I solid tumour studieso Cardiovascular – stenting and PFO closureo Infectious diseases – vaccination studieso Rheumatoid arthritis• Development and review of SOPs• Development of database containing information on Research Centres across New Zealand,… Show more • Site feasibility, selection, initiation/set-up, ongoing monitoring and site management and close-out activities in the following therapeutic areas:o Oncology – colorectal, breast, prostate and lung cancer, as well as phase I solid tumour studieso Cardiovascular – stenting and PFO closureo Infectious diseases – vaccination studieso Rheumatoid arthritis• Development and review of SOPs• Development of database containing information on Research Centres across New Zealand, including patient populations and centre facilities• Certified ACRP CRA and certified ACRP trainer Show less

• Feasibility, site-selection, set-up and monitoring of centres in the UK, including mentoring new CRAs for phase III diabetes studies • Assisting colleagues with site maintenance issues and close-out of insulin and haemostasis studies, encouraging co-monitoring and consistent training among colleagues• Acting as a trainer for Investigator GCP courses

• Responsible for phase I studies involving human drug absorption of NCEs and more established investigational products• Preparation of CRFs according to protocol and monitoring of all study data, including real time monitoring• Protocol preparation and review according to Sponsor requirements• Completion of initiation and close-out meetings with site staff to ensure timely completion of quality data within budget and also meeting with Sponsor monitors to discuss all areas of the… Show more • Responsible for phase I studies involving human drug absorption of NCEs and more established investigational products• Preparation of CRFs according to protocol and monitoring of all study data, including real time monitoring• Protocol preparation and review according to Sponsor requirements• Completion of initiation and close-out meetings with site staff to ensure timely completion of quality data within budget and also meeting with Sponsor monitors to discuss all areas of the trial Show less

• Monitoring of phase III IGT study at 9 sites, including hospitals and SMOs• Use of Impact computer systems to record and track data appropriately

• Co-ordinating and monitoring phase IIIb/IV cardiovascular study as part of a large team of CRAs involving 450 primary care sites