Richa Dave

1. Research Quality System Management and Regulatory Compliance

• Designed, implemented, and managed robust quality systems and processes in alignment with NCTGF accreditation standards and regulatory compliance requirements.
• Led the implementation of the Mater Clinical Governance Framework for clinical trials and spearheaded the development of the Mater Research Governance Framework to optimise trial operations and enhance oversight.
• Developed an internal quality audit framework for Mater Research in collaboration with external stakeholders, identifying opportunities for continuous improvement and advancing research governance practices.
• Directed the Research Quality Team in implementing quality management systems to strengthen research outputs and embed a culture of excellence and accountability.
• Established and maintained Quality Improvement and Assurance activities, including the development of new policies and procedures and the ongoing management of Mater Research guidance documents on the Mater internal SharePoint platform (MPPL).
• Introduced a structured system for the identification, reporting and management of safety incidents, including the creation of Serious Adverse Event (SAE) and Corrective and Preventive Action (CAPA) registers.
• Effectively managed and resolved clinical trial-related complaints, ensuring timely resolution and full compliance with institutional and regulatory standards.

2. Research Support and Stakeholder Engagement

• Built and maintained strong, trusted relationships with Mater researchers, promoting a culture of transparency, collaboration, and mutual respect.
• Delivered high-level strategic and operational guidance to the Mater Research Executive and researchers on internal policies, national research standards MPPL and preparation for NCTGF SNAP assessments.
• Actively contributed to fostering a culture of continuous quality improvement within the Research Compliance team by promoting policy alignment, process consistency and best practice implementation across the organisation.
• Led the design and development of the Mater Research NCTGF SharePoint evidence site, MR human cell line register for biomedical researchers, provided comprehensive ERM training and user support and implemented operational enhancements to Early Phase Clinical Trial processes.

1. Strategic Leadership and Policy Advancement

• Led statewide engagement to drive progress on the Clinical Trials Strategic Action Plan (CTSAP) and the National Clinical Trials Governance Framework (NCTGF).
• Represented Queensland on the Southern and Eastern Border States (SEBS) clinical trial agreements review panel and at the ARCS Clinical Summit, contributing strategic recommendations on Clinical Trial Research Agreements and ICH GCP E6 (R3) revisions.
• Provided state-level policy advice to clinician researchers in a simplified, actionable format, supporting the development of effective multidisciplinary research teams.

2. Stakeholder Engagement and Ecosystem Building

• Effectively liaised with internal and external stakeholders across Queensland, fostering strong collaboration across clinical, academic and industry sectors.
• Advanced the growth of the Queensland Clinical Trials Consortium (200 plus members) by coordinating bi-annual collaborative meetings with industry partners, clinical trial managers and researchers to strengthen the state’s clinical trial ecosystem. These partnerships led to Queensland achieving the highest number of local client engagements at Bio Japan 2023.

3. Research Development and Operational Support

• Promoted research collaboration by enabling site feasibilities, providing clinical trials budgeting support, preparing detailed clinical trial activity reports and supporting new site capability-building.
• Provided hands-on support to researchers, understanding operational challenges and enhancing their clinical trial readiness and competitiveness.

4. Team Management

• Supervised Senior Project officer in development of the Qld Clinical Trials Portal.

1. Stakeholder Engagement and Ecosystem Growth

• Actively engaged with new clinical trial sites and service providers, resulting in a significant increase in QLD Clinical Trials (CT) Portal listings and expanded reach across the state’s clinical trial network.
• Facilitated weekly collaboration with technical teams at EBSCO, clearly communicating end-user needs from sponsors, CROs, clinicians and researchers’ perspective, enhancing system responsiveness and user alignment.

2. Digital Transformation and System Enhancement

• Led the uplift and transformation of the QLD CT Portal, improving its visibility, usability (recommended Bento box searches) and sustainability to better support the clinical trials and research community.
• Contributed strategic recommendations for the CT Portal Tranche 1 Project (May 2023), streamlining the portal into a single, intuitive workflow that generates actionable insights and enhances site–sponsor matching.

1. Research Strategy and Collaboration

• Advanced collaborative research efforts within one of QLD’s busiest public vascular surgery units, partnering with clinicians, industry and academic researchers to drive publications, trials and research outputs.
• Was Invited to present at Queensland Society For Vascular Nursing (QSVN) to provide guidance to nurses on how to undertake research in QLD public hospitals and how to advance their research careers by applying for research grants.
• Mentored junior medical staff in developing and advancing research projects during their training, leading to peer-reviewed publications and enhanced career development opportunities.
• Prepared multi-disciplinary grant and Dossier applications to secure research funding and surgical equipment for the department.

2. Clinical Trials and Research Management

• Successfully led and coordinated national and international multicentre clinical trials (e.g., EVAR, ECST2, MERIT, industry sponsored device/medicine trials) at PA Hospital, managing ethics submissions, research governance, site coordination, budget negotiations, participant recruitment, training of medical and nursing staff and data analysis.
• Oversaw project timelines and deliverables, collaborating with senior vascular surgeons, clinical teams, and external sponsors to ensure smooth project execution and compliance.

3. Clinical Audit and Quality Improvement

• Led data analysis and prepared monthly morbidity and mortality (M&M) audit repots for the Vascular Surgery unit and hospital wide. Utilised The Viewer and SurgiNet to extract and analyse patient, surgical, and radiology data, supporting clinical quality improvement and patient safety initiatives.
• Supported the Queensland Audit of Surgical Mortality (QASM) peer-review process by providing clinical data, liaising with surgeons and coordinating with external bodies like forensic services.

4. Team Management

• Supervised and trained Vascular surgery nurses to undertake research projects and participate in clinical research. Promoted nursing staff involvement in clinical trials by applying for research grants and collaborating with the Nurse Unit Manager to negotiate budgets, enabling clinical nurses to take on research nurse roles.

5. Technical and Data Management Skills

• Utilised and adapted to dynamic hospital IT systems- Cerner PowerChart, and PowerTrials to effectively manage surgical audits; upskilled in R, SPSS, RedCap and other research data and clinical trial management systems.
• Led data-driven reporting for audits, clinical trials and activity-based funding initiatives.
• Recieved Honour code Certificate in “Statistics and R for the Life Sciences” from Harvard University through edX.

1. Strategic Planning and Governance

• Incorporated lessons learned from previous MSH RSS funding rounds and feedback from key stakeholders, including the Executive Director, Metro South Research, MSH Research Council and Study, Education and Research Trust Account (SERTA) Committee.
• Ensured that any changes to RSS funding arrangements received endorsement and approval from the MSH Research Grants Committee and relevant funding bodies (e.g., SERTA Chair, PA Research Foundation, external sponsors).

2. Policy and Process Development

• Developed and maintained fit-for-purpose RSS funding guidelines and supporting Early Career Researchers (ECRs) (offering more support through pre-submission review), clinicians and other researchers.
• Created an initial assessment checklist for application completeness and eligibility and defined clear evaluation and weighting criteria for the review process.
• Designed and refined the RSS assessment process in consultation with the Executive Director, Metro South Research.

3. Operational Management

• Managed and supervised lead statisticians in MSH Biostatics and Bioinformatics Clinics run by Queensland Facility for Advanced Bioinformatics (QFAB) across Metro South Health sites, Queensland Health.
• Managed a small administrative team within CHR, including a Grants Administration Officer and ad-hoc research office staff who supported the grants process.
• Recommended the transition of application submission processes- from manual email-based submissions to the Smarty Grants system (has been implemented since).
• Liaised with applicants and business managers across departments to ensure accurate budgeting and acquittals and documentation of all research-related costs, including in-kind contributions.

4. Support and Engagement

• Provided advice and support to Principal Investigators, researchers and student supervisors to ensure compliance with all relevant MSH research policies and procedures during RSS and external (NHMRC, Heart Foundation grants etc) applications.
• Identified a gap in pre-submission support for researchers and initiated a new series of workshops for researcher clinicians- “Statistical considerations in Grant writing”, to help researchers design more accurate project proposals for successful grant applications.
• Coordinated the promotion and announcement of RSS grants in collaboration with the Executive Director and MSH Events, Media and Communications.
• Attended the Australian Research Council (ARC) and National Health and Medical Research Council (NHMRC), ARC/NHMRC Research Administrators Seminar in November 2016, Canberra to gain updated knowledge on grants administration.

• Mentored and guided junior trainee doctors at the PA hospital to advance their research skills by undertaking research projects relevant to their clinical practice.
• Guided the junior research medical staff in successfully publishing their research in peer reviewed journals and presentations at medical conferences.

• Gained excellent organisational skills, time management skills, ability to perform under pressure and the ability to multi-task.
• During this time, I wrote two first author manuscripts and edited student research PhD and MSc degree thesis.

1. Research Leadership and Project Management

• Led and managed national and international collaborative research projects with globally recognised researchers, resulting in multiple peer-reviewed publications in leading journals.
• Delivered high-impact experimental results across complex, multidisciplinary projects using advanced molecular biology, genomics technologies and bioinformatics tools.
• Developed high-quality scientific content, including grant applications, publications, and presentations, supporting both funding success and research dissemination. Was invited as a Grant Reviewer for Samantha Dickson Brain Tumour Trust, UK

2. Training, Supervision and Mentorship

• Led the training and development of research staff and students, supporting project planning, experimental design, data collection, and analysis across multidisciplinary teams.

3. Innovation and Technical Development

• Optimised and developed novel research methodologies, assessed current technologies and contributed to the strategic planning and procurement of advanced research infrastructure.

4. Stakeholder Engagement and Collaboration

• Established and maintained strong, effective relationships with internal and external stakeholders over a five-year tenure.

5. Science Communication and Outreach

• Volunteered as a Science Ambassador for the Institute for Molecular Bioscience, University of Queensland, promoting STEM education and engaging the wider community in science outreach initiatives.

1. Research Outputs and Intellectual Property

• Published four first-author peer-reviewed articles based on doctoral research.
• Contributed to the filing of an Australian provisional patent (Application No. 2007902300), titled “Inflammation target and therapy therefor”, submitted on 2 May 2007.

2. Collaborations and Industry Engagement

• Collaborated extensively with leading academic institutions and industry partners, including AstraZeneca (UK), Monash University, The University of Melbourne and prominent research group leaders.
• Selected as a Visiting Research Scientist at RIRA, AstraZeneca, Alderley Park (UK), undertaking a three-month research placement at AstraZeneca.

3. Teaching and Academic Contribution

• Delivered undergraduate tutorials in Microbiology for Medicine, Dentistry, Molecular Biology and Chemical Engineering courses at The University of Queensland.

4. Scientific Communication and Conferences

• Presented research findings at numerous national and international scientific conferences through oral presentations and seminars.
• In 2006, Iwas awarded best poster prize at the Queenstown Signal Transduction Meeting and “X-factor Student” award at the Bio-business retreat organized by the commercial wing of Institute of Molecular Biosciences.

• Utilization and optimization of molecular biology techniques to over-express beta subunit of human chorionic gonadotropin gene in yeast (Yarrowia lipolytica), to accomplish large-scale production of the recombinant protein for use in medical diagnostics (pregnancy kits).