•To consent patients for the research•To submit ethics applications or amendments if required (in association with the Investigators)•To enter clinical details on a purpose built database and maintaining and updating the clinical database.•To monitor patient results (in conjunction with the investigators)•To ensure that follow up surveillance tests and investigations are undertaken in a timely manner and to encourage adherence to the study protocols•To generate data and participate in data analysis, data presentation and the write up of manuscripts.•To be involved in coordinating meetings between the investigators•Maintenance and filing of appropriate study related documents including patient visits•Assist in maintaining and updating the department’s other clinical databases.•Liaise with medical, nursing, pharmacy, pharmaceutical companies and allied health staff•Communicate with patients to schedule their appointments •To use iPM software to enter patients detail and schedule appointments.•To use Ezymad software for Medicare Billing•To generate invoice for Clinical Trial related Billing•Maintain knowledge and skills in current clinical practice•Adhere to the policies and standards of the Clinical Support Service, Westmead Hospital and appropriate legislation and statutory regulations.

• Receipt and data entry of patients’ samples and patients’ information into the laboratory information system.• Appropriate handling of pathology specimens.• Working within a team based customer service environment.• Preparation of samples for laboratory testing i.e. Checking patients’ details, attaching bar-code and aliquoting samples if needed.• Answering telephone inquiries• Find samples from the storage room for added tests• Scanning and Storage of request forms.

• Identification of potential subjects in consultation with PI• Administration of ICF• Assist in screening, randomization and subsequent subject visits• Schedule subject visits to ensure subject compliance and subject retention• Ensure that all information required by CRF is present in hospital source documents• Use IVR System for various applications during the study• Timely completion of CRFs• Assist in resolution of queries / DCFs• Ensure compliance to the protocol, SOPs and applicable regulatory requirements• Responsible for Study Drug receipt, accountability, storage and dispensing to study subjects as per the protocol• Communicating with CRO and sponsor• Attend site selection visit, site initiation visit, monitoring visit, closeout visit• Reporting SAEs and safety reports to IRB/IEC• EC Submission • Update investigator site file on regular basis• Participate in investigator meeting and study related teleconferences