Research Group: Status: Hours: Salary: Reports to: Clinical Trials Assistant POSITION DESCRIPTION Haematology Clinical Trials Part-Time for one (1) year. Role is renewable based on performance and funding 33 hour over five days $45,000 per annum pro rata. Salary packaging is available In the first instance, the Haematology Clinical Trials Manager, then the Director of the Haematology at Liverpool Hospital and the Institute s Human Resources Manager Background The Ingham Institute for Applied Medical Research (the Institute) is a not-for-profit organisation located in Sydney s South West that undertakes medical research that specifically addresses, and can be applied to, the needs of the local population and wider Australia. The Institute is integral to a unique collaboration with the South Western Sydney Local Health District, Western Sydney University and the UNSW Sydney. The Liverpool Hospital Haematology Clinical Trials Unit operates in a family-friendly, supportive and team-focused environment. All team members of the team are provided ongoing support and training. The team consist of 12 Haematologists, 8 Advanced Trainees, the Clinical Trials Manager, Clinical Trials Coordinators, and a Clinical Trials Pharmacist. A Clinical Trials Assistant is sought to work with the Haematology Clinical Trials Unit and will be based at Ingham Institute. Purpose of Position The Clinical Trials Assistant will: Provide support for clinical trials within Liverpool Hospital and the South Western Sydney Local Health District. Assist with the effective and timely management of clinical trials activities and help build the profile of clinical research. Assist in the preparation of Human Research Ethics Committee (HREC) and Governance submissions. Enter data into study specific database and ensure accurate and timely data entry and record keeping, including patient recruitment and study documentation, within the electronic database system and other repositories. Version: Jun 2018 Page 1 of 5
Undertake basic clinical examination of patients (Training provided). Assist the trial team in participant recruitment, treatment and follow-up interviews; this will include telephone calls and face-to-face meetings with participants. Collection and Processing blood products in line with the study specific protocol (Training provided). Organise individual work tasks related to particular trial deliverables and document the team's deliverables and milestones. Maintain trial supply inventory and liaise with external vendors as instructed. Maintain Investigator Site File. Other task delegated by Clinical Trials Manager. Criteria Essential Criteria: Degree in health science or nursing. Previous experience in Clinical Trial Administration role in Australia. Strong organisation skill with highly developed project planning, coordination and time management skills. Experience in a similar professional environment with proven ability to identify problems, make recommendations and implement appropriate solutions in the research environment. High level interpersonal skills and proven ability to work strategically with key stakeholders in a research environment. Well-developed written and verbal communication skills, as well as consultation and interpersonal skills. High level computing skills, including databases, clinical trial electronic data entry, word processing and spreadsheets. Proven proficiency in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook, Adobe Writer, Adobe Pro as well as database applications. Desirable Criteria: Basic Knowledge of clinical research practices, ethical obligations, ICH and Good Clinical Practice. Demonstrated ability to maintain high work standards with minimum supervision and an ability to ensure other team members work in accordance to Standard Operating Procedures relevant to clinical trial conduct. Ability to work in a team and support a team environment. Version: Jun 2018 Page 2 of 5
Key Accountabilities Clinical Trials Administration Duties Project planning and administration. Key Performance Indicators Trial/Study Management Manages and directs Document tracker/checklist, which is accessible to all members of the trials office. Manages and directs necessary documents for ethics preparation and submission and liaises effectively with the Australian Leukaemia and Lymphoma Group (ALLG) Trial Centre staff or Clinical Research Associates of pharmaceutical sponsored studies. Initiates and implements submission to the Human Research Ethics Committee (HREC) and RGO for approval. Meets deadlines with Human Research Ethics documents such as, REGIS/HREA, Site Specific Application (SSA), Variations, Annual Reports, Serious Adverse Events (SAE s), Amendments to Protocols. Effectively directs the management of communication with Participating and Lead sites. Directs Annual and Final Reports to HREC in a timely manner. Liaises effectively with HREC regarding trial documents, submissions, variations and SUSAR s. Creates and maintains a spreadsheet data base of all study participants enrolled in haematology trials. Downloads documentation for studies from the Australasian Leukaemia Lymphoma Group (ALLG) website for ALLG studies. Effectively manages of Clinical Trial Site Folders. Updates and sends 6 monthly trial summaries to the Clinical Cancer Research Network. Develops and implements standard operating procedures (SOPs) for the Version: Jun 2018 Page 3 of 5
administrative tasks in Haematology Trials Office. Manages and Maintains updating of information on MOSAIQ. Responds to telephone calls from study patients regarding their enquires and to relay or leave communication for the Research nurses or haematologists in an understandable manner. Develops and maintains forms and templates for study and finance purposes for manager and trial coordinators to facilitate in presentations of new and current trials for multidisciplinary haematology meetings. Communication Understand and ensure WHS requirements and responsibilities. Liaises effectively with haematologists, nurses, administration staff and drug company representatives sponsoring our studies to achieve successful outcomes Manages all communication with Participating and Lead sites effectively Demonstrates proficiency in word processing, scanning and email. Accuracy is evident in the management of entry of patient details onto enrolling/screening logs. Provides accurate and timely minutes (typed) of regular haematology group meetings for circulation. Complies with the Institute s WH&S Statement and WH&S Policy and Procedures Is always mindful of workplace safety as it pertains to self. 100% of accidents are reported within 24 hours. Proper use is made of all relevant safety equipment. Attends training programs as directed. Work as an Ingham Institute team member. Is an effective team member. Attends Institute staff meetings and, where applicable, shares information Version: Jun 2018 Page 4 of 5
available at these meetings with unit staff. Complies with Ingham Institute Code of Conduct. Contributes to the research culture at Ingham Institute. Participates in Ingham Institute supporting activities. Version: Jun 2018 Page 5 of 5