Kathryn Goss
Frankston,Australia
Summary
Experienced professional with over 16 years in clinical research and project management, currently advancing my knowledge through Public Health studies. While I am new to mental health policy writing and implementation, my background in managing complex workflows, ensuring compliance, and delivering results ahead of schedule has prepared me to contribute effectively to this field. Known for my meticulous attention to detail, strong work ethic, and collaborative approach, I am dedicated to leveraging my project management skills and personal insights into mental health to support the development and execution of impactful mental health policies. My commitment to improving health outcomes and driving continuous improvement positions me as a proactive and valuable addition to the mental health sector.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Monash Cardiovascular Research Centre
05.2023 - Current
- Oversee the start-up, execution, and completion of clinical trials at Monash Heart and Victorian Heart Hospital, ensuring adherence to research protocols and regulatory requirements
- Identify, screen, and recruit eligible participants for clinical studies, including obtaining informed consent and maintaining accurate participant records while ensuring confidentiality
- Collect, enter, and verify study data, ensuring accuracy and completeness in source documentation; proficient in Electronic Medical Records and study-specific electronic databases
- Prepare and submit necessary documentation to ethics committees and regulatory bodies, ensuring compliance with local and international guidelines
- Coordinate with multidisciplinary teams, including researchers, healthcare professionals, and external stakeholders, to facilitate study processes and ensure effective communication
- Monitor study progress, manage adverse events, and prepare detailed progress reports for stakeholders and regulatory authorities
- Communicate effectively with pharmaceutical companies, using strong interpersonal skills to ensure data accuracy and adherence to study protocols
- Ensure all study procedures and activities are conducted in accordance with approved research protocols, maintaining the integrity of the research
- Provide training and support to research staff and investigators on study procedures and regulatory requirements
- Assist in managing study budgets, procuring resources, tracking expenditures, and negotiating budgets with pharmaceutical companies
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Streamlined patient visit schedules, reducing wait times and increasing patient satisfaction.
- Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
- Improved data integrity and accuracy with meticulous oversight of data collection processes.
Senior Clinical/Translation Research Coordinator
Pancreatic and Biliary Cancers, Dr Daniel Croagh
01.2022 - 05.2023
- Managed Investigator Initiated Trials (IITs) and Translation studies, including the Pancreatico-biliary Cancer Biobank, overseeing comprehensive project management and data analysis
- Coordinated with Monash Health Research Directorate for project advice, ethics approvals, and maintained rapport with key stakeholders
- Developed and maintained critical documentation, including the Laboratory Manual, Biospecimen Transport SOP, and Data Management Plan for Gastrointestinal Cancer Research
- Advised clinicians and investigators on clinical research studies, ethical considerations, and ensured compliance with trial guidelines
- Managed research budgets and grants in collaboration with Monash University and handled invoicing and annual progress reports
- Liaised with Principal Investigators and participating sites to gather bio specimen data and updated the Pancreatico-biliary Cancer Biobank
- Prepared and maintained regulatory Master study files, ensuring secure, de-identified data storage and compliance with privacy standards
- Developed the Standard Operating Procedure for the Pancreatico-biliary Cancer Biobank and built relationships with Biobanking Victoria
- Negotiated budgets with external researchers and contributed to the Gastro-Intestinal Trials Group
Endoscopy Senior Clinical Research Coordinator
Endoscopy Research, Dr Michael Swan
07.2018 - 05.2023
- Managed research governance submissions, negotiated budgets, and oversaw ethics maintenance, including protocol amendments
- Coordinated participant pre-screening, site file management, and hospital department logistics for patient visits and sample processing
- Utilised IWRS and IVRS for trial management and maintained study documentation, including regulatory binders and source documents
- Communicated with CROs, managed delegation and training logs, and designed clinical research documentation
- Administered Endoscopy study databases with REDCap and built relationships with Monash Health Research Directorate for project advice and ethics approvals
- Prepared HREC and Research Governance Office applications, assisted with participant screening, recruitment, and data collection, ensuring compliance and research integrity
- Supported data cleaning, presentation, publication preparation, and managed research finances, including sponsor negotiations
- Prepared and delivered detailed presentations for key stakeholders at Boston Scientific, aimed at securing funding for future research projects
- This involved crafting compelling narratives, presenting data insights, and addressing potential concerns to align with the strategic goals of potential sponsors
Clinical Trials Ethics Research Assistant
Haematology Research Unit, Monash Health
01.2019 - 01.2022
- Managed ethics submissions, maintained sponsor communication, and streamlined approval processes in line with National Health and Medical Research Committee guidelines
- Developed tracking systems and managed study protocols
- Maintained communication with commercial sponsors and pharmaceutical companies to streamline ethics submissions
- Streamlined study start-up and ethics approval processes by maintaining communication with sponsors, securing site-specific certifications, and facilitating timely submissions
- Worked with Haematology Research Managers and Principal Investigators to prioritise studies and submissions
Senior Technical Assistant/Research Support Staff
Ovarian Cancer Research Foundation, Hudson Institute of Medical Research
01.2018 - 01.2019
- Identified potential ovarian cancer patients for research sample collection, actively participating in surgeries to obtain various biological samples, including urine, blood, endocervical swabs, and fresh ovarian tissue.
- Ensured sensitive donor consent was obtained and adhered to ethical guidelines when handling patient information.
- Traveled between multiple hospital sites for sample collection, maintaining close communication with head surgeons, chief investigators, registrars, and anaesthetists to ensure seamless collaboration.
- Processed blood samples and aliquoted plasma into 1ml vials, ensuring appropriate processing of tissue samples to safeguard patient care and optimize future research use.
- Actively participated in multidisciplinary meetings to identify potential donors for ongoing research studies.
- Updated and managed the REDCap database system to ensure accurate data tracking and reporting.
- Developed key relationships with hospital departments and enhanced project coordination and management skills, demonstrating a commitment to impactful research in ovarian cancer
Project Liaison Officer
Victorian Cancer Biobank (VCB), Melbourne Health
08.2008 - 01.2018
- Played a crucial role in advancing cancer research through effective project management and collaboration.
- Developed a comprehensive understanding of VCB Standard Operating Procedures (SOPs), including DNA Extraction from FFPE and Tissue Microarray SOPs, ensuring adherence to protocols and contributing to their refinement.
- Created templates for accurate labelling of biospecimens, promoting consistency in sample identification.
- Successfully screened and recruited potential cancer participants for tissue donations for future research, demonstrating strong recruitment skills and a commitment to research advancement.
- Maintained utmost sensitivity when interacting with patients and their families, understanding the emotional context of their cancer diagnosis, and ensuring compassionate communication throughout the donation process.
- Demonstrated attention to detail by capturing clinical data using hospital health systems and processing blood samples for research groups.
- Managed fresh tissue handling and conducted DNA and RNA extractions, showcasing technical proficiency in these areas.
- Attended outpatient clinics to obtain donor consent sensitively, reinforcing strong communication skills while ensuring confidentiality of patient information.
- Maintained effective working relationships with Surgeons, Nurses, Pathologists, and Researchers, facilitating teamwork to support research goals.
- Coordinated donor consent, sample collection, and data management for clinical trials, highlighting project management abilities.
- Trained new staff members and interns on VCB SOPs, fostering a culture of compliance and collaboration.
- Communicated with the RMH Colorectal Liaison Nurse to recruit potential colorectal cancer patients, exemplifying stakeholder engagement skills.
- Ensured optimal processing and storage of tissue samples to uphold patient care and future research integrity.
- Enhanced visibility and impact of work by attending early morning clinics and presenting Tissue Bank statistics at multidisciplinary meetings.
- Honed skills in policy development, communication, clinical data management, and attention to detail, reinforcing commitment to advancing cancer research
Project Coordinator
Walter and Eliza Hall Institute of Medical Researc
06.2011 - 06.2012
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments.
- Enhanced team collaboration through regular meetings, fostering a positive work environment for increased productivity.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- dvanced breast cancer research as a Project Coordinator through effective project management and collaboration.
- Successfully identified and recruited 400 breast cancer participants, enhancing project inventory while adhering to strict timelines.
- Meticulously collected and managed clinical data from hospital health systems to ensure accuracy and integrity.
- Led the generation of FFPE Tissue MicroArrays and performed DNA extraction, demonstrating technical proficiency and high attention to detail.
- Amended and submitted Human Research Ethics Committee (HREC) applications, upholding regulatory compliance and ethical standards.
- Contributed to the publication of "200 Ki67/BCL2 Index: Impact on Prognosis in Australian Women" (Asia-Pac J Clin Oncol 2016; 12(suppl.S5):66-168), showcasing commitment to impactful research outcomes.
- Produced comprehensive reports for funding presentations, enhancing communication with stakeholders and fostering key relationships with hospital departments.
- Honed skills in project management, stakeholder engagement, and regulatory compliance, driving passion for improving healthcare outcomes through research.
Education
Post-Graduate Certificate - Public Health
Victoria University
02.2025
Post-Graduate Diploma - Human Nutrition
Deakin University
Melbourne, VIC01.2015
Bachelor of Science - Biotechnology
RMIT University
Melbourne, VIC01.2007
Diploma of Science - Biotechnology
RMIT University
Melbourne, VIC01.2005
Skills
- Project management and coordination
- Effective communication
- Professional demeanor with strong interpersonal skills
- Proactive problem-solving
- Proficient in Microsoft Office
- Development of research Standard Operating Procedures and policies
- Database management
Certification
- Good Clinical Practice Certificate, 07/01/24
- Working with Children Check, 06/01/23 - 06/01/28
Volunteer Experience
Women’s Coordinator, Mornington Peninsula Hockey Club, 2022 and 2023, Led and coordinated various aspects of the women’s hockey program, including organising events, managing schedules, and overseeing team activities., Facilitated communication between team members, coaches, and stakeholders to ensure smooth operations and address any issues., Advocated for the needs and interests of female players, working to enhance their participation and experience within the club., Developed and implemented strategies to improve team performance and member engagement, demonstrating strong project management skills., Supported players’ health and well-being by providing resources and fostering a supportive environment, addressing both physical and mental health needs to promote overall team welfare.
Professionalreferees
Available upon request
Timeline
Clinical Research Coordinator
Monash Cardiovascular Research Centre
05.2023 - Current
Senior Clinical/Translation Research Coordinator
Pancreatic and Biliary Cancers, Dr Daniel Croagh
01.2022 - 05.2023
Clinical Trials Ethics Research Assistant
Haematology Research Unit, Monash Health
01.2019 - 01.2022
Endoscopy Senior Clinical Research Coordinator
Endoscopy Research, Dr Michael Swan
07.2018 - 05.2023
Senior Technical Assistant/Research Support Staff
Ovarian Cancer Research Foundation, Hudson Institute of Medical Research
01.2018 - 01.2019
Project Coordinator
Walter and Eliza Hall Institute of Medical Researc
06.2011 - 06.2012
Project Liaison Officer
Victorian Cancer Biobank (VCB), Melbourne Health
08.2008 - 01.2018
- Good Clinical Practice Certificate, 07/01/24
- Working with Children Check, 06/01/23 - 06/01/28
Post-Graduate Certificate - Public Health
Victoria University
Post-Graduate Diploma - Human Nutrition
Deakin University
Bachelor of Science - Biotechnology
RMIT University
Diploma of Science - Biotechnology
RMIT University
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