The Project Assistant is required to assist the Project Manager and Study Team with various tasks associated with running a large scale research project. Generally, the Project Assistant is responsible for assisting the project team in the ongoing execution and closeout of the trial.
This position will report to Project Manager
Duties and Key Responsibilities
• Assist in the preparation of study documentation, forms and the development of administrative systems and processes
• Assist in the preparation and distribution of study documents to investigators and site staff
• Assist in the planning and preparation of Investigator meetings
• Maintain up to date participating centre’s information (including all contact details, contracts and reports).
• Assist in the development of administrative systems and processes, preparation and distribution of study documents to investigators and site staff.
• Assist with the collection, review and tracking of regulatory documents
• Responsible for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation and destruction.
• Responsible for the maintenance and filing of study administrative files
• Assist in managing effective communication with the participate centres.
• Assist with administration of the study including monitoring study progress, responding immediately to queries.
• Travel with the project manager to visit the local centres
• Assist with preparation of data for final analyses and filing and archiving of clinical study data at end of study.
• Assist in developing, monitoring and reporting against project timelines
• Assist project team with other study related activities such as organizing study meetings and scheduling travel, producing agendas and minutes for study-related meetings, assembling training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of administrative documents and other tasks as required.
• Be familiar with OHS regulations and other institute policies that are applicable to all Institute staff (such as HR policies and procedures, resource sharing, etc).
• Participate in team meetings and activities related to the Diabetes Research Program, and the institute as a whole.
• Participate in objective setting, performance management, review of the position and the planning and implementation of personal and career development activities. Actively develop job-related skills.
• Participate in special projects to continuously improve processes, tools, systems and organisation.
As a Team Member:
• Participate in team meetings and activities
• Participate in objective setting and performance management
• Participate in special projects to improve processes, tools, systems and organization of GI China
Occupational Health and Safety
• Comply with OH&S legislation and operate in accordance with established OH&S practice and procedures at The George Institute
• Promote and contribute to a safe, secure environment for staff and visitors
Skills, Knowledge, and Experience
• Preferred experience in a clinical research environment
• Basic knowledge of clinical trial processes and ICH/GCP guidelines desirable
• Good understanding of medical terminology.
• General administration skills and experience desirable.
• Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint, Outlook and the Internet.
• Excellent attention to detail while remaining able to attend to strategic issues
• Excellent written, verbal and interpersonal communication skills and the ability to work well flexibly (i.e. autonomously), in small teams and with a wide range of varying stakeholders.
• Willingness and ability to travel.
• Understanding of confidentiality and privacy laws and guidelines relevant to medical research.
• Well organized with good time management skills;
• Motivated and able to work independently and unsupervised.