POSITION DESCRIPTION Clinical Trials Unit Manager Clinical Trials Unit

Position Title Clinical Trials Unit Manager

Division Clinical Trials Unit

Position Purpose The Clinical Trials Unit Manager oversees the activities of the Clinical Trials Unit at Mater Research. The position is responsible for the implementation and conduct of and clinical trials at the highest standard, in alignment with the strategic direction of Mater Research and Mater. The role leads a multi-disciplinary team, developing and implementing strategies for ensuring the conduct of clinical trials at Mater through Mater Research is consistent and efficient, and meets all relevant regulatory standards. The role liaises with a wide range of internal and external stakeholders, managing complex relationships to achieve growth in activity. These objectives support the promotion of high-quality research and delivery of exceptional, evidence-based healthcare.

Location Aubigny Place, South Brisbane

Occupational Professional Level 9 Category and Level Reporting Relationship Director of Operations

Review Date 01 March 2021

Next Review Due 01 March 2022

Staff Member TBC Signature Date

Direct Emily Bailey Signature Date Supervisor

1. OVERVIEW

Mater Group As a Catholic not-for-profit ministry of Mercy Partners, Mater Group is committed to meeting the healthcare needs of our community through an integrated approach to our health education and research services, which is focused on delivering the highest quality care for our patients. For more than a century in Queensland, Mater has been defined by an abiding commitment to meeting the healthcare needs of the community.

Today, our Mission and Mercy Values continue to guide Mater people in making appropriate decisions for a sustainable, socially relevant healthcare service that is genuinely committed to the community it serves. Mater Group comprises Mater Health, Mater Education, Mater Research and Mater Foundation.

Mater Research Mater Research (MR) is a world-class institute that is committed to conduct, enable and translate clinically relevant health research. With more than 300 laboratory and clinical researchers working across Mater's hospitals and the world-class Translational Research Institute (TRI), Mater Research is committed to working closely with Mater Health, Mater Education and our growing network of partners to turn scientific discovery into the best possible treatment, care, and outcomes for patients and our broader community.

Our teams conduct outstanding research into: • Cancer • Chronic and Integrated Care • Mother and Baby • Neurosciences • Health Care Delivery and innovation

Mater Research Institute – The University of Queensland MRI-UQ is an alliance between Mater Research and UQ, providing strategic benefits to both partners. Mater Research brings to the alliance considerable clinical collaboration opportunities and UQ brings all its expertise as a research, education and teaching institution. Mater Research employees, through an affiliation to MRI-UQ have access to world-class research infrastructure and systems.

Translational Research Institute (TRI) Focusing on a wide range of health and areas, the Translational Research Institute (TRI) is a joint venture between Mater Research (MR) The University of Queensland Diamantina Institute (UQDI), Queensland University of Technology’s Institute of Health and Biomedical Innovation (IHBI), and the Princess Alexandra Hospital’s Centres for Health Research. The Translational Research Institute brings these research facilities together with the aim to improve and accelerate the translation of medical research into greater patient care.

2. HOURS

This is a full-time position and working hours will be mutually agreed with the appointee’s supervisor.

3. PURPOSE OF POSITION

The Clinical Trials Unit Manager oversees the activities of the Clinical Trials Unit at Mater Research. The position is responsible for the implementation and conduct of clinical research and clinical trials at the highest standard, in alignment with the strategic direction of Mater Research and Mater. The role leads a multi-disciplinary team, developing and implementing strategies for ensuring the conduct of clinical trials at Mater Research is consistent and efficient, and meets all relevant regulatory standards. The role liaises with a wide range of internal and external stakeholders, managing complex relationships to achieve growth in clinical trial activity. These objectives support the promotion of high- quality research and delivery of exceptional, evidence-based healthcare.

4. POSITION DESCRIPTION 4.1 Strategic Direction • Lead the Clinical Trials Unit to maintain and enhance Mater Research’s reputation for the highest standard of clinical trial conduct. • Develop and deliver a strategic plan for the growth of industry sponsored and investigator led clinical trial activity at Mater sites across Queensland through Mater Research. • Ensure relevant policies are developed and implemented that are responsive to changes in clinical research management, public policy, and the political environment. • Develop mechanisms to ensure external legislation and best practice codes are implemented and adhered to. • Develop appropriate systems to capture performance data and provide reports on performance to stakeholders with strategies for addressing identified problem areas and opportunities. • Investigate and implement measures to work towards consistent contracts covering employment conditions for all clinical research staff. • Develop and implement policies and procedures for efficient trial budgeting and recovery of operating costs. • Represent Mater Research Clinical Trials Unit on appropriate internal and external committees • Liaise with internal and external stakeholders to ensure efficient and quality outcomes are met for the Clinical Trials Unit and Mater Research. • Assist the Mater Research Executive team to identify and implement strategies to improve Mater’s success in attracting competitive research funding for clinical research. • Develop strong relationships with all internal and external stakeholders to promote the Clinical Trials Unit, ensure efficient resource utilisation, and drive business growth.

4.2 Clinical Research Activities • Coordinate the smooth conduct of all clinical research in the unit by identifying and managing qualified research staff, including a flexible pool of Research Co-ordinators, Research Assistants, and other relevant clinical research staff. • Leverage resources, expertise, and knowledge across projects to create efficiencies. • Ensure all clinical research applications submitted for HREC and research governance are of the highest quality to assist in fast turnarounds, and reduction of the impact of regulatory processes on research timelines. • Provide leadership to the Research Program Co-ordinators to develop mechanisms to ensure researchers are supported to meet their regulatory requirements for their research projects. • Develop systems to support financial management of the clinical research programme including budget planning, resource allocation and preparation of regular reports. • Develop systems to support project management, resulting in the successful delivery of clinical research projects.

• Ensure that all aspects of Good Clinical Practice (GCP) are always complied with, including through provision of training at start-up and initiation meetings for clinical trials and on-going standard operating procedures development. • Ensure adherence to Mater policies and relevant external legislation and guidelines. • Support Program Coordinators with identifying and resolving issues associated with the conduct of clinical research. • Identify emerging trends/regulations in clinical research while proactively integrating these elements into policies and procedures within the relevant stream. • Ensure strategies to meet anticipated participant recruitment at appropriate rates to meet study objectives and timelines are implemented and their success monitored. • Promote clinical research support staff to undertake ongoing training and to assist in the preparation and dissemination of research results. • Work with the Facilities team to develop the clinical trials facilities on the Mater campuses.

4.3 Education and Communication • Implement training programmes for clinical research staff with topics such as principles and practices of project management, team communication, and CRF writing, adverse event reporting and the importance of budget control. • Initiate forums and processes for training, mentorship and knowledge sharing within the Clinical Trials Unit and Mater Research. • Establish and maintain effective communication networks to facilitate efficient conduct of clinical research with relevant collaborators and/or industry sponsors within the relevant stream. • Promote consumer awareness and engagement of the role of clinical research within the Mater campuses and externally. • Maintain currency with relevant health professional and educational practice and industry requirements. • Publish relevant processes and findings in peer-reviewed publications and other forums.

4.4 Human Resource Management • Provide effective supervision to team members, identify training needs, and manage overall performance of this role in accordance with Mater Research HR policies promoting an environment of continuous improvement. • Conduct Employee Performance reviews in accordance with Mater Research Performance Development Program. • Anticipate changes in workload of team and plan accordingly, liaising with the Human Resources Business Partner and Mater Research Executive team as appropriate. • Promote a safe working environment, complying with relevant health and safety policies, procedures, and hazard reporting practices. • Ensure a working understanding of contemporary human resource management issues, including Workplace Health and Safety, Equal Employment Opportunity and Anti- Discrimination.

4.5 Expression of Mater Values • Promote and demonstrate the mission and objectives of Mater Research, and the philosophy and values of the Sisters of Mercy. • Demonstrate personal attentiveness, sensitivity and non-judgemental manner when interacting with team members. • Demonstrate values-based decision-making and leadership.

5. PRIMARY DELEGATIONS AND ACCOUNTABILITIES This position reports to the Director of Operations. This position directly supervises the Program Coordinators in the Clinical Trials Unit. The position is responsible for complying with Mater Research’s Code of Conduct and Policies and Procedures.

6. INTELLECTUAL PROPERTY Mater Research will require the assignment of all rights, in and to all discoveries, and inventions made, developed, or devised while working at or under the guidance of the Mater Research, during the term of the appointment.

7. SELECTION CRITERIA

Qualifications

Essential • An appropriate postgraduate qualification or progress towards a qualification in the areas of public health, clinical trials co-ordination, project management or a relevant clinical discipline • Current Good Clinical Practice (GCP) certification.

Highly Desirable • Business or project management-related qualification.

Experience Essential • Proven experience in project management and/or health research program management • Significant experience in the coordination of health-related research, including experience in the set-up and conduct of industry sponsored clinical trials. • Demonstrated ability to lead a multidisciplinary team to meet deadlines, drive business improvements and create a culture of effective team participation • Significant experience in working effectively with a wide range of stakeholders and managing complex internal and external relationships in a dynamic environment.

Highly Desirable • Contribution to publications, conference papers, reports or professional or technical contributions • Experience in data collection, data management, statistical analysis • Experience in attracting funding opportunities.

Knowledge and Skills Essential • Thorough understanding of financial management principles and experience in managing a cost centre or business unit • Solid understanding of the regulatory, ethics and governance requirements of clinical trials and experience in leading the development of research related procedures or protocols and ethics and governance applications • Demonstrated high level of communication and interpersonal skills including the ability to build strong and sustainable relationships to achieve consensus and drive success • The ability to perform under pressure and with minimal supervision, using problem solving skills and exercising judgement as required

• Demonstrated understanding of, and commitment to, the Australian Code for the Responsible Conduct of Research and the NHMRC National Statement on Ethical Conduct in Research Involving Humans • Advanced digital literacy and computer skills (e.g. Microsoft Office, clinical trial management software programs)

Highly Desirable • Demonstrated understanding of, and commitment to, the Catholic Health Australia Code of Ethical Standards.

Personal Qualities Essential • Strong time management and organisational skills • Personal attributes of integrity, initiative, sound judgement and respect for confidentiality • Commitment to the promotion of the Philosophy and Mission of the Mater Misericordiae Ltd.

8. REVIEW The position will be subject to mutual review on an annual basis, and the incumbent will engage in an annual performance review.