Clinical Trials Research Officer

Clinical Trials Research Officer

Reports to Melissa Kermeen Department of Gastroenterology and Liver Services Concord Repatriation General Hospital Organisational area Faculty of Medicine Position summary Reporting to the Director of Liver Services, the Clinical Trials Research Officer will form part of the team managing current clinical trial participants' treatment regimens and coordinating current and future research projects of the department. This is essential for maintaining good clinical practice and for the ongoing capabilities of the department. The research conducted by our department contribute to better health outcomes for patients, provide training and education for medical students and junior medical officers, and play an integral part in the professional and academic development of our staff members. More information about the specific role requirements can be found in the position description at the end of this document. Location Concord Hospital Type of appointment Full-time or part time maternity leave position. Salary Remuneration package: $91, 819 p.a. (which includes a base salary Level 6 $82,098 p.a., leave loading and up to 10.5% employer s contribution to superannuation). How to apply All applications must be submitted online via the University of Sydney careers website. Visit sydney.edu.au/recruitment and search by reference number 2190/1017 for more information and to apply. 1

For further information For information on position responsibilities and requirements, please see the position description attached at the end of this document. Intending applicants are welcome to seek further information about the position from: Melissa Kermeen Department of Gastroenterology and Liver Services Concord Repatriation General Hospital 02 97675563 Melissa.Kermeen@health.nsw.gov.au For enquiries regarding the recruitment process, please contact: Sarah Daji Talen Acquisition Consultant 02 8627 6362 sarah.daji@sydney.edu.au

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POSITION DESCRIPTION POSITION DETAILS: POSITION TITLE SCHOOL / DEPARTMENT FACULTY / PSU REPORTS TO Clinical Trials Research Officer Concord Clinical School/Gastroenterology and Liver Services Sydney Medical School Director Of Liver Services CLASSIFICATION LEVEL HEO6 POSITION NUMBER CLASSIFICATION DATE 21 May 2015 PRIMARY POSITION ACTIVITY Research General Support CLASSIFICATION CODE CAT15346 PRIMARY FUNCTION: Provides technical knowledge and expertise to the Chief Investigator, Senior Research Academics and the research team to support the research and/or clinical trial requirements for the work area. This includes actively contributing to research activities and undertaking core aspects of research work. Collates and records research data, and reports information from the research undertaken. When working in a laboratory prepares a variety of biological samples for shipment to local and international laboratories. OVERVIEW OF THE SCHOOL / DEPARTMENT AND POSITION CONTET The Department of Gastroenterology and Liver Services at Concord Repatriation General Hospital is part of the Concord Clinical School which provides training and education to medical students and junior medical officers. The Department has educational facilities for a broad range of clinical presentations in both outpatient and inpatient settings and is a leading clinical research group in the field of Gastroenterology and Hepatology. The Clinical Trials Research Officer will form part of the team managing current clinical trial participants' treatment regimens and coordinating current and future research projects of the department. This is essential for maintaining good clinical practice and for the ongoing capabilities of the department. The research conducted by our department contribute to better health outcomes for patients, provide training and education for medical students and junior medical officers, and play an integral part in the professional and academic development of our staff members. PD created using Standard Position Profile (September 2014)

CAT15346 Clinical Trials Research Officer_NLynch_20 5 15 doc KEY ACCOUNTABILITIES: Delete the activities that are not relevant to the role 1. Assists with the conduct and documentation of designated clinical trials. Verifies eligibility of potential patients for the trials Makes scheduled appointments for trial patients Conducts patient visits/interviews for clinical trials, arranging interpreters where required Arranges study medication prescriptions for patients and collect from pharmacy Organises collection of blood and urine specimens from patients according to protocol timelines Performs vital signs and urinalysis for patients according to protocol timelines Processes blood samples Coordinates shipment of serum and urine samples to central laboratories Arranges medical tests and appointments for patients according to the trial protocol timelines Completes and submit the trials data forms on schedule Organises submission of Serious Adverse Events trial data forms to sponsor companies in a timely manner As a Registered Nurse administers study medication to patients via protocol required routes of administration. 2. Conducts data analysis and literary searches, aids in preparing preliminary reports for the work area. Ensures that data collected is entered into the appropriate database for analysis and that records are kept appropriately. Works with colleagues to resolve simple non-routine issues that might arise in the course of daily activities associated with the research project. 3. Conducts research work as part of the broader Research agenda for the work area. Undertakes research under some guidance of the Chief Investigator and in collaboration with other senior research staff. Provides technical expertise to the Research team to guide the collection of clinical trial data. Monitors, catalogues and reports on the progress of the clinical trial work undertaken to the Chief Investigator or senior research staff. Ensures laboratory records are maintained, detailed and up to date. Communicates with the Chief Investigator about progress of clinical trial work and provides day-to-day management and support to staff and patients. Liaises with clinical specialists and affiliated researchers/collaborators regarding study progress and outcomes. Attends clinical trial investigator meetings and conferences 4. Specific research activities include: Conducts research tests as required; for example Neurological tests, pregnancy tests, administers questionnaires Prepares cultures/samples from dissections of human tissue. Collects and prepares tissue samples for transport to local or international laboratories. Organise meetings and presentations by pharmaceutical sponsor companies 5.. Undertakes ad-hoc projects and other activities. Assists with the training of new staff members Is responsible for the Supervision of casual staff when required Maintains the inventory of clinical trial supplies Coordinates and processes clinical trial payments from pharmaceutical sponsor companies Frequency Ongoing Ongoing Ongoing Ongoing 20 May 2015 Page 2

CAT15346 Clinical Trials Research Officer_NLynch_20 5 15 doc KEY RELATIONSHIPS INTERNAL across/within the University MAIN CONTACT FREQUENCY PURPOSE Clinical trials Coordinator, Consultant Gastroenterologists and Hepatologists, medical students, junior medical officers and ancillary departments involved in clinical research (ie. Department of Radiology/Department of Surgery) ETERNAL outside of the University Daily MAIN CONTACT FREQUENCY PURPOSE Pharmaceutical companies and Clinical Research Organisations As required These contacts are required for the care and management of clinical trial patients. In accordance with trial needs and protocol. DECISION MAKING AND DELEGATIONS OF AUTHORITY The Clinical Trials Research Officer works under broad guidance and exercises independent judgement in the performance of research activities and tasks on established research projects. They will usually receive clear instruction on the research objectives that need to be achieved and will typically draw from their previous experience in this field to successfully deliver on key accountabilities. They will be asked to provide sound advice related to the research work they are undertaking with highly complex issues referred to more senior researchers, often including options on what could be done to resolve the issue. The incumbent is expected to carry out routine tasks fairly autonomously, with minimal guidance and/or supervision once process/procedure is agreed upon and/or learnt. Non-routine complex research matters may be carried out under broad guidance from the Chief Investigator. The job-holder will be expected to prioritise their own work to meet any deadlines and project needs. The Clinical Trials Assistant will make decisions on patient scheduling and tests required in consultation with physicians and department heads and in line with the trial protocol. Where a person is designated Head of Administrative Unit (HOA), the Delegations of Authority - Administrative Rule applies. POSITION DIMENSIONS STAFF DATA DIRECT REPORTS: number of direct reports to this position, their classification and number of incumbents INDIRECT REPORTS: number of reports via subordinates to this position FACULTY / PSU SIZE SCHOOL / DEPARTMENT SIZE NA NA >200 Staff ~100 staff/ ~10 staff FINANCIAL DATA SALARY BUDGET NON-SALARY BUDGET GRANT AMOUNTS / BUDGET OTHER AMOUNTS Nil ~60-80000 per annum Nil Nil 20 May 2015 Page 3

CAT15346 Clinical Trials Research Officer_NLynch_20 5 15 doc EPERIENCE, SKILLS AND QUALIFICATIONS CRITERIA ESSENTIAL DESIRABLE Tertiary qualifications in appropriate discipline with relevant experience in related field. May have (or be working towards) completing further studies or have extensive specialist experience in the field of research. Excellent interpersonal, verbal and written communication skills with sound negotiating and conflict resolution skills and a demonstrated level of tact and discretion in dealing with day to day operational matters. Ability to work both independently and as part of a team, taking initiative and exercising sound judgement in resolving matters that may arise as part of normal daily work. Strong problem solving skills and the ability to use initiative and exercise sound judgement and ability to prioritise workload during busy periods Numeracy skills together with experience in controlling income/expenditure for reconciliation/budget tracking, and managing invoice payments and purchases. Extensive experience in working on research projects, including expertise in using research protocols, experimental design and ethics submissions.. Accuracy and attention to detail Experience in a research-intensive environment or interest in teaching and working in academia Working understanding and current knowledge of relevant aspects of the Work Health and Safety Policy and relevant legislation (including Safe Laboratory Practices for roles based in Laboratory). Peripheral venous cannulation/venepuncture Experience in the management of patients in an outpatient department within a clinical trial setting Registered nurse or other allied health qualifications Thorough knowledge of medical terminology WORKING WITH CHILDREN If the position involves working with children, a Working with Children Check clearance must be obtained. Please refer to the Working with Children Policy for further information. If appropriate to the role, please type Yes to indicate that a Working with Children clearance is required or No if the position is not child-related: Yes / No EQUAL EMPLOYMENT OPPORTUNITY / AFFIRMATIVE ACTION Demonstrated understanding of the incorporation into University life of the principles of Equal Employment Opportunity and Affirmative Action EOOnline; and ability to work positively with staff and students from a diverse range of backgrounds. WORK HEALTH AND SAFETY (WHS) Understand your WHS responsibilities and actively ensure the health, safety and wellbeing of yourself and others at work in accordance with the University s WHS policy and procedures and as described in the role responsibilities on the WHS website. 20 May 2015 Page 4

CAT15346 Clinical Trials Research Officer_NLynch_20 5 15 doc ORGANISATIONAL CHART SIGNATURE The line manager and delegated authority confirm that this is a true reflection of the duties and accountabilities of this role. LINE MANAGER DELEGATED AUTHORITY SIGNATURE SIGNATURE DATE DATE Kindly Note: The line manager and delegated authority may be the same person. If this is the case, only one signature is required. 20 May 2015 Page 5