Grace Edwards
Melbourne,VIC
Summary
Experienced Study Coordinator proficient in managing multiple clinical trials, ensuring adherence to ethics and governance standards, budget allocation, and participant recruitment. Skilled in meticulous data management and protocol adherence, maintaining high standards of quality and regulatory compliance. Known for effectively coordinating study timelines, resources, and budgets while prioritizing participant safety and satisfaction. Committed to contributing personal expertise and passion for clinical research to support your team in achieving company goals. Dedicated to ongoing professional development and eager to progress in Clinical Research career while continually striving for improvement
Overview
5
5
years of professional experience
Work History
Movement Disorders Study Coordinator
The Royal Melbourne Hospital
04.2023 - Current
- Project Oversight and Management: Oversaw multiple concurrent clinical trials within Movement Disorder team with up to 20 participants and budgets of $400,000 or more, ensuring efficient allocation of resources and adherence to study timelines.
- Regulatory Compliance and Documentation: Maintained meticulous documentation to ensure regulatory compliance, managing Investigator Site files and overseeing staff completion of protocol-specific training.
- Ethics and Governance Oversight: Prepared and submitted ethics and governance applications for 5 new trials, where we served as lead HREC (Human Research and Ethics Committee), ensuring compliance with ethical standards and regulatory requirements.
- Resource Allocation and Budget Management: Optimized resource allocation for research projects, effectively managing budgets and personnel requirements to streamline study operations.
- Participant Engagement and Retention: Developed and implemented participant retention strategies, including creation of engaging materials highlighting benefits of continued study involvement, fostering a high retention rate.
- Clinical Visit Coordination: Orchestrated study visit schedules, coordinating staff and patient availability to maximize efficiency and data collection, while preparing subject folders for visits according to protocol-specific procedures.
- Clinical Assessment Administration: Conducted study visits in compliance with ICH/GCP and FDA regulations, administering clinical assessments to ensure participant safety and well-being.
- Communication and Collaboration: Facilitated effective communication between participants and research team, fostering collaboration and ensuring accurate data collection, while organizing and leading interdisciplinary team meetings to provide progress updates and promote collaboration.
Movement Disorders Research Assistant
The Royal Melbourne Hospital
04.2022 - 04.2023
- Supported Research Projects: Assisted with various aspects of 10 research projects, including data collection, participant recruitment, literature reviews, and report writing.
- Data Management: Collected and managed clinical research data for over 40 participants, ensuring accuracy and adherence to protocols.
- Administrative Assistance: Provided administrative support, including management of approximately 30 incoming calls and 100 emails per day, organizing meetings, maintaining records, and facilitating communication.
- Ethics and Governance Support: Assisted with ethics and governance submissions for 10 research projects, ensuring compliance with regulatory requirements and ethical standards.
- Team Collaboration: Collaborated with interdisciplinary teams to facilitate research progress and achieve objectives.
Analytical Technician
Hydroxsys Ltd
01.2021 - 01.2022
- Research and Development Support: Provided comprehensive support to quality departments, contributing to improved analytical processes and procedures.
- SOP Development: Assisted in developing SOPs, methodologies, and timelines to ensure compliance with quality standards.
- Research Coordination: Coordinated quantitative and qualitative research with a team of three researchers to facilitate efficient project execution.
- Data Management: Prepared and managed data entry samples, ensuring accuracy in company's research database.
- Adaptability: Demonstrated versatility in completing diverse tasks, contributing to team and organizational success.
- Report Submission Support: Supported project managers in submitting detailed reports, enhancing decision-making based on accurate data analysis.
Laboratory Demonstrator
University of Auckland
03.2019 - 11.2020
- Facilitation of Molecular Biology Course: Presented fundamental concepts, methodologies, and test-taking strategies to undergraduate students in a required Molecular Biology course, fostering understanding of key principles.
- Educational Materials Development: Developed summaries, outlines, and exam questions to aid student comprehension and assessment preparation, ensuring alignment with course objectives and academic standards.
- Student Support and Management: Provided support to approximately 30 students during laboratory classes, assisting them with experiments, troubleshooting, and conceptual understanding. Managed student groups during lab sessions to ensure safety and adherence to protocols.
- Student Assessment: Graded student assignments and exams, providing constructive feedback to support academic growth and achievement.
Education
MBiomedSc - Reproductive Genetics And Physiology
University of Auckland
Auckland, New Zealand05.2021
Postgraduate Diploma in Biomedical Science - Project Design, Analysis, And Research Techniques
University of Auckland
New Zealand05.2020
Bachelor of Science - Genetics And Developmental Biology
University of Otago
Dunedin, New Zealad11.2018
Skills
- Clinical Research and Data Management
- Ethics and Regulatory Submissions and Compliance
- Interdisciplinary Collaboration
- Participant Recruitment and Engagement
- Good Clinical Practices
- Strong Organizational and Critical Thinking abilities
Accomplishments
- Presentation of Masters Research at Journal Club (Auckland Zoo), May 2021.
- Oral presentation at HealtheX, University's student-led conference, September 2020.
- Summer Research Scholarship in Department of Biological Sciences and Dairy NZ, November 2018 - February 2019.
Timeline
Movement Disorders Study Coordinator
The Royal Melbourne Hospital
04.2023 - Current
Movement Disorders Research Assistant
The Royal Melbourne Hospital
04.2022 - 04.2023
Analytical Technician
Hydroxsys Ltd
01.2021 - 01.2022
Laboratory Demonstrator
University of Auckland
03.2019 - 11.2020
MBiomedSc - Reproductive Genetics And Physiology
University of Auckland
Postgraduate Diploma in Biomedical Science - Project Design, Analysis, And Research Techniques
University of Auckland
Bachelor of Science - Genetics And Developmental Biology
University of Otago
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