Luke Stacey Email & Phone Number

Sydney, New South Wales, Australia

Sydney, Australia

Sydney, Australia

Sydney

Sydney, Australia

• Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial
• Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables
• Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for inclusion in a contract modification
• Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to external/internal clients/vendors
• Manage contingency planning for data cleaning; clinical data listings review; and, coordinate process for reviewing data listings by clinical team
• Prepare monitoring plan, as well as responsible for the implementation and training of standardized clinical monitoring processes within the study team

Sydney, Australia

Monitor eight sites running a metastatic Colorectal Cancer study and one site running a Hepatits C from SIV, through recruitment and ongoing data analysis in accordance with ICH-GCP.Complete monitoring visit reports per company SOPs Collection and in house maintenance of regulatory documents from sites Discuss recruitment strategies with clinical trial.

Monitor clinical trials sites across a number of therapeutic areas including melanoma, sarcoma and breast cancer to ensure patient safety and to ensure the trial is being run in accordance with ICH GCP, the protocol and company SOPs Complete monitoring visit reports per company SOPs Collection and in house maintenance of regulatory documents from.

Monitor clinical trials sites across a number of therapeutic areas including melanoma, lung cancer, sarcoma, breast cancer and flu to ensure patient safety and to ensure the trial is being run in accordance with ICH GCP, the protocol and company SOPs Complete monitoring visit reports Assist sites in the preparation of ethics submissions Collection and in.

Monitor clinical trials in accordance with ICH GCP and company SOPsAssist sites in the preparation of ethics submissions Collection of regulatory documents from sites

Monitor clinical trial sites across a number of therapeutic areas including, melanoma, breast cancer, pancreatic cancer, invasive aspergillosis, pediatric medulloblastoma and rheumatoid arthritis in accordance with ICH GCP and company SOPs. Act as Lead CRA on two melanoma studies and one pancreatic cancer study Assist sites in the preparation of ethics.

Monitor clinical trials in accordance with ICH GCP and company SOPsAssist sites in the preparation of ethics submissions Collection of regulatory documents from sites

Monitor clinical trials (2 sites in an epilepsy trial) in accordance with ICH GCP and company SOPsAssist 5 sites in the preparation of ethics submissions for an idiopathic pulmonary fibrosis study. Collection of regulatory documents from sites

- Review clinical data for correctness and completeness and to GCP and company SOP standards- Issue queries and track query resolution

Bsc, Molecular Biotechnology And Pharmacology

Higher School Certificate