Wesley Medical Research (WMR) is a not-for-profit organisation that conducts research that focuses on improving patient care and quality of life. Our clinical and applied research aims to discover, test and refine new techniques for better diagnosis and treatment of illness and disease. The organisation's research projects are conducted by its employees, clinicians at The Wesley Hospital and other UnitingCare Health hospitals, in collaboration with other UnitingCare agencies, industry, research organisations and universities.

Wesley Medical Research’s aim is to create a research precinct across the UnitingCare Health hospitals, including The Wesley Hospital and St Andrew’s War Memorial Hospital, to increase the involvement of the community and trial participants in the research process, enhance the reputation for high quality research, increase research capacity and to support investigator-initiated research.

The brief is to attract and undertake:

• Commercially sponsored Clinical Trials
• Investigator-Initiated Research for projects that are clinically focused

The principal purpose of the Clinical Research Physician position is to support the various clinical trials by performing critical trial-related procedures and/or making important trial-related decisions in a team environment. This position may also assume overall responsibility as an Investigator for allocated clinical trials.

Clinical Trial Responsibilities

• Support the Theme Leaders in all duties as directed
• Assume delegated responsibility from the Principal Investigator (PI) for trial-related medical decisions for all allocated clinical trials
• Conduct trials in compliance with the protocol agreed to by the sponsor
• If appointed as a PI, will have overall responsibility for the team and will delegate trial-related duties/tasks appropriately to qualified staff
• To work collaboratively with the PI on any investigator-initiated trials
• Be responsible for fully informing participants and obtaining informed consent according to regulatory requirements and Good Clinical Practice (GCP) guidelines
• Oversee the welfare and medical care of the participants in relation to the trials
• Be available for all urgent participant matters
• Read and understand trial protocols, consent forms, investigator brochures, and other study specific manuals
• Coordinate with the Theme Leaders to be available for all significant trial setup and monitoring visits as requested by the Theme Leaders or Sponsor
• Assist the Clinical Research Coordinator (CRC) in confirming patients' eligibility for entry to a trial
• Ensure the accuracy, completeness, legibility and timelines of the data reported to the sponsor
• Record substantive study-related conversations
• Assist with the preparation of study specific tools and record management system as necessary
• Participate in CRC meetings to discuss recruitment and study progress
• Collaborate with all Organisational staff to develop a constructive team orientated environment which provides a positive experience to sponsors, trial participants, external contractors and other Organisational staff
• Actively participate in staff meetings and in-service education where appropriate
• Assist the Theme Leaders with the implementation of continuous improvement processes to improve operations of the department

Note: Participant enrolment and follow up may necessitate some after-hours involvement
for this position

Research Governance

• Ensure all research activities managed by the department are carried out in accordance with Good Clinical and Laboratory Practice (GCP & GLP) and in line with National Health and Medical Research (NHMRC) standards and Australian laws and regulations
• Ensure adherence to the Privacy Act 1988 Sections 95 and 95A and maintain confidentiality
• Ensure all research activities are conducted in accordance with Standard Operating Procedures (SOPs) and research specific protocols
• Assist in the development of regulatory frameworks that adhere to industry and government standards for the centre
• Complete accurate, timely and comprehensive records with verifiable source documentation
• Use and contribute to the systems used for the management of data within the centre
• Participate in the review and amendment of SOPs

Regulatory Affairs Responsibilities

• Ensure all relevant trial information is communicated to the Human Research Ethics Committees (e.g. UnitingCare Health - HREC)
• Where applicable, oversee administrative processes relating to HREC reporting

PI/Co-I Related Responsibilities

• Work with the CRC/ Co-I to ensure quality and continuity of care for study participants
• Review and sign required trial documents

Clinical Responsibilities

• Perform protocol specific medical assessments and procedures (including cannulation, where applicable)
• Maintain and update clinical competencies necessary for the studies

Sponsor Related Responsibilities

• Attend Investigator meetings and site initiation meetings as directed
• Communicate with the sponsor's representatives regarding study activities and respond to data queries in a timely manner
• Be available for trial close-out visits, as necessary

Adverse Event (AEs) / Serious Adverse Event (SAEs) Responsibilities

• Have a full understanding of Adverse Events and Serious Adverse Events and the reporting process in accordance with Good Clinical and Laboratory Practice (GCP & GLP), sponsor requirements and the Organisation's policies
• Ensure the reporting of all serious and/or unexpected adverse events to the appropriate authorities

 Occupational Health and Safety

 WMR views the safety of its employees, contractors, visitors, patients and the surrounding environment as a responsibility essential to our foundational values of 'justice' and 'stewardship'. It is also essential to our long–term success.
All WMR Employees will:

• Follow all Safe Operating Procedures in the workplace.
• Have a responsibility to take reasonable care of themselves and their fellow workers during their employment.
• Will not interfere, bypass or misuse any system or equipment provided for health, safety and welfare purposes.
• Will take all actions to avoid, eliminate or minimize hazards.
• Seek information on any work they undertake and be aware of the risks and hazards associated with their work.
• Report all incidents/ hazards/ injuries.
• Participate in the documentation of Risk Assessments and Safe Operating Procedures for activities that could pose an OHS risk.
• Use Personal Protective Equipment as required and directed.
• Attend all mandatory and recommended OHS training as scheduled by WMR
• Promote a positive safety culture within their areas by demonstrating a positive commitment to OHS.

Position Reporting Structure

The position reports directly to the Director of Research. The following key relationships are an essential component of the position:-

Internal:

• Theme Leaders  
• CRC Team

 External:

• Trial Sponsors and their representatives
• PI/Co-Is
• Clinical trial participants
• HREC

Requirements

Essential

• A medical degree/qualifications and current registration with Medical Board of Australia
• A minimum of three years medical experience
• Up to date Good Clinical Practice (GCP) certification (this can be provided by WMR)
• Demonstrated ability to work both independently and in a multi-disciplinary team in an effective, proactive and co-operative manner
• High level of initiative and flexibility and ability to meet deadlines while balancing multiple priorities
• Must hold a valid Queensland's driver's license
• A flexible attitude, including the capacity to acquire new skills and multi-task
• Excellent organisational skills and the ability to prioritise tasks effectively
• Excellent interpersonal skills, including the ability to interact effectively with patients and multi-disciplinary medical and scientific staff
• A proactive attitude
• Ability to maintain confidentiality at all times
• Strong written and oral communication

Desirable

• Clinical trials experience or otherwise research experience
• Knowledge of The Wesley Hospital and UnitingCare Health policies and regulations which impact upon the position
• Understanding of Good Clinical and Laboratory Practice (GCP & GLP) and National Health and Medical Research (NHMRC) standards and relevant Australian laws and regulations
• Experience in cannulation

Submit your Resume and Cover Letter outlining your suitability for this role by 5pm Friday 21st April via:      careers@wesleyresearch.com.au