Research Assistant

**About us**:
The Bionics Institute is an internationally recognised, independent medical research institute that solves medical challenges with technology.

We lead the world in the research and development of innovative medical devices and therapies to improve human health. Our multidisciplinary team comprises world-class scientists, engineers and researchers, and our laboratories are located in St Vincent’s Hospital Melbourne, close to our clinical collaborators.

Together we transform the lives of people with a range of conditions, including hearing impairment, Crohnʼs disease, Parkinson’s disease, epilepsy, stroke, arthritis, and diabetes.

**About you**:
You will have an undergraduate degree with honours in a relevant area and experience in clinical research.

Your strengths will be in interpersonal and communication skills, including written and verbal skills.

You will have high-level organisational skills, including the ability to set priorities, multi-task, manage time, plan work to meet deadlines and work effectively under pressure, with a proven ability to work independently in and as part of a busy team.

You will additionally have a demonstrated understanding of confidentiality, privacy and information handling principles and an awareness of research guidelines and protocols.

**About the role**:
We are looking for a Research Assistant to join the Cognitive Therapeutics Research Program, led by Professor Kate Hoy.

The Cognitive Therapeutics Research Program conducts clinical trials of brain stimulation treatments in cognitive disorders, including Alzheimer’s disease.

The research assistant will work on clinical trials, primarily involving the use of novel brain stimulation techniques in the treatment of Alzheimer’s disease.

The primary role will be coordination and collection of data for a clinical research trial

**Key responsibilities**:

- Assist in the successful completion of essential research trial activities:

- Trial coordination, including recruitment, screening, assessment, and monitoring of study participants
- Accurate collection, entry, and maintenance of participant data
- Coordination of trial visits, appointments, assessments, and treatments with research participants and/or their carers as required
- Contacting participants and arranging follow-up appointments in the event that they withdraw or suffer any adverse event(s)
- Providing research participants and their carers with accurate study related knowledge at appropriate intervals, responding to queries in a timely and professional manner
- Referral of clinical trial participants to clinical team members and/or appropriate services according to trial SOPs if required
- Assist in conducting research according to study protocols and relevant legal and regulatory bodies including International Conference of Harmonisation (ICH) and ISO14155 Good Clinical Practice (GCP) guidelines
- Adhere to research specific instructions, policies, standard operating procedures, guidelines and reporting requirements
- Assist in organisational and ethics committee reporting
- Protect confidential information from unauthorised disclosure
- Professionally engage key internal and external stakeholders
- Maintain appropriate and effective communication with key internal and external parties, including investigators, Bionics Institute team members, external service providers, research participants, and their carers and clinicians where required.
- Successful team integration and support
- Work with understanding and cooperation within a multidisciplinary team of researchers, including clinicians, engineers, and data scientists.
- Actively be engaged and involved in team meetings
- Provide support for other colleagues and studies within Bionics Institute as requested
- Meet all governance standards and benchmarks required for clinical research.
- Knowledge and implementation of Ethics and Governance requirements, and ICH-GCP guidelines
- Assist in the accurate and timely preparation of Human Research Ethics Committee (HREC) and/sponsor documentation for study submission and amendments, progress, safety, and final reports
- Assist in the accurate and timely preparation of safety and Adverse Event reporting to investigators, HRECs and study sponsors where required.
- Participates in all professional and personal development requirements.
- Undertake and maintain all required training including Good Clinical Practice training or refreshers, study specific training, mandatory training and all internal training as required.
- Other duties as directed

**Core Competencies for the Role**:
**Task complexity (Routine)**

**Knowledge required (General)**

Knowledge of materials, equipment, processes, and procedures applicable to the work area. Some awareness of theoretical or policy context. Sound knowledge of work area processes and understanding of how these interact with other workgroups or areas within the organisation.

**Level of supervision