Belinda Dresser

• Manage the site, study team, and sponsor expectations from feasibility to site activation.
• Coordination and preparation of EC and regulatory (TGA/Medsafe) submissions in Australia and New Zealand.
• Negotiate site contracts and budgets with sites, if applicable, and track the progress of contract and budget milestones/developments, intervening and escalating as appropriate.
• Communicate with global study teams and sponsors on study progress, and identify/mitigate risks to site activation.
• Perform required activities within the country that lead to the activation of investigative sites in all phases of clinical trials, including GMO studies.
• Provide expertise and guidance to global study teams in ethics and regulatory submissions.
• Act as the main contact for ethical and regulatory submission-related activities, ensuring submissions comply with applicable regulations and guidance documents.
• Direct contact with investigative sites during the study start-up and activation process.
• Advise sponsors on changing regulations and compliance requirements.
• Track submissions and ensure timely filing of documents.
• Ensure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines.
• Serve as the primary contact for investigative sites, and ensure that the required documents are collected in a timely manner. Proactively manage sites to ensure timely site activation, and escalate study issues appropriately and in a timely fashion. Participate in team meetings to progress trials and identify site issues that might impact the timelines.
• Preparation of site activation project-specific plans and providing accurate projections and timelines to study teams agreed upon with the sponsor.
• Review and customize country- and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues, and other potential difficulties with study sites.
• Ensure high-quality documents are filed, and systems are updated on an ongoing and timely basis for audit readiness.
• Undertake tasks delegated by senior team members or management, depending on country and situational requirements.
• Subject Matter Expert for GMO studies.
• Experience with OGTR accreditation and DNIR/DIR license applications.
• Support for other, less experienced team members with process and role-related queries.

Oversight and coordination of the Multiple Sclerosis, Dermatology, Rheumatology, and Respiratory clinical trials teams.

• Leadership of a diverse team of professionals, including research coordinators, data managers, and clinical staff, to ensure that clinical trials are conducted effectively and in compliance with regulatory standards.
• Collaborating with investigators to implement trial protocols ensuring they are executed according to ICH-GCP guidelines.
• Ensuring that all trials comply with ethical standards, institutional policies, and regulatory requirements. Including preparation for audits and inspections.
• Oversight of the financial aspects of clinical trials, including budgeting, funding allocation, and expense tracking, to ensure financial viability.
• Development of strategies for patient recruitment and retention, working closely with clinical staff to identify eligible participants, and maintain engagement throughout the study.
• Overseeing data collection and management processes, ensuring accuracy, integrity, and confidentiality of trial data.
• Responsible for the procurement of an electronic source vendor selection.
• Primary liaison between stakeholders, including sponsors, regulatory agencies, and hospital administration, to facilitate smooth communication and collaboration.
• Provision of training and support to team members, ensuring they are knowledgeable about trial protocols, ethical considerations, and compliance requirements.

• Leading a team of nurses and support staff to ensure high-quality patient care. This includes hiring, training, evaluating staff performance, and fostering a collaborative team environment.
• Ensuring patients receive safe, evidence-based care by assessing patient needs, coordinating care plans, and monitoring patient outcomes.
• Managing the daily operations of the department, including scheduling procedures, maintaining equipment, and ensuring that the facility meets regulatory and accreditation standards.
• Implementing and monitoring quality assurance programs to enhance patient safety and care quality. This includes reviewing/updating SOPs, conducting audits, and addressing areas for improvement.
• Working closely with physicians, radiologists, cardiologists, and other healthcare professionals to coordinate care and ensure optimal patient outcomes. This includes participating in case discussions and care planning.
• Overseeing the departments' budget, managing supplies and equipment, and ensuring cost-effective use of resources while maintaining high standards of care.
• Providing coordination of ongoing education and training for nursing staff and other team members to keep them updated on the latest techniques, technologies, and best practices in medical imaging and cardiac care.

• Registered Nurse, Medical Imaging / Cardiac Catheter Lab, Eastern Health, Box Hill - March 2002 - June 2004.
• Registered Nurse, Post-Anaesthetic Care Unit, Alfred Health - Feb 2000 – March 2002.
• Registered Nurse, Cardiothoracic Unit, Alfred Health - Feb 1994 - Feb 2000.