Medical Research Specialist
6 days ago
The Medical Monitor is a key member of our global clinical trials team, responsible for providing medical and academic input to various aspects of our studies. This role ensures project delivery is of high quality, operationally aligned, cost-effective, and competitive.
Key Responsibilities- Provide medical and academic expertise for new and existing studies.
- Support Endpoint Adjudication and other relevant Committees where required.
- Provide medical input to safety and endpoints documents and to project plans and documents as required.
- Represent George Clinical and its values with academic colleagues, commercial customers, vendors, government, and regulatory bodies as requested.
- Participate in team meetings and activities as required.
- Ensure activities comply with relevant Acts, legal demands, and ethical standards.
- Provide clinical input into the development and/or review of study protocols, procedure manuals, data collection tools, and data quality plans.
- Review query reports generated from project databases to identify errors and inconsistencies, as outlined in the medical monitoring plan.
- Provide ongoing, continuous support to the sites by taking and answering queries related to medical issues around patient eligibility, recruitment, treatment, and management, and adverse events, etc., as outlined in the scope of the medical monitoring plan.
- Develop and provide protocol training from a medical perspective for project investigators and CRAs for the assigned projects, as required.
- Provide input into ongoing training and education materials for project investigators, e.g., study newsletters.
- Liaise with project teams, data management, endpoint coordinators, investigators, site staff, sponsors, and endpoint adjudicators as needed.
- Provide clinical input into the development of endpoint adjudication manuals, plans, charters, tracking tools, and associated documentation.
- Provide medical review and input to endpoint packages as required.
- Liaise with internal and external stakeholders as appropriate.
- Provide clinical input to development of safety manuals, plans, charters, tracking tools, and associated documentation.
- Where contracted, review and provide narratives for Serious Adverse Events reported on George Clinical trials according to timelines described in the project plans.
- Provide medical advice and guidance for George Clinical Safety team.
- In collaboration with line manager, contribute to the development and provision of therapeutic area training for George Clinical staff regularly.
- Review literature and participate in conducting research that relates to the direct activities or interests of The George Institute and George Clinical.
- Tertiary qualifications in medicine.
- Experience and expertise in clinical research.
- Understanding of academic research.
- Working knowledge of current ICH/GCP, ethical, and regulatory requirements.
- Highly developed interpersonal, relationship-building, and negotiation skills.
- Excellent communication skills, including verbal, written, and presentation skills.
- Ability to travel domestically and internationally.
- Technological proficiency, including Microsoft Office packages.
- Ability to see the big picture, yet still focus on detail and quality of work.
- Ability to be flexible and adaptable in changing organizational priorities and ambiguous environments.
We are a global clinical research organization founded in Asia-Pacific, driven by scientific expertise and operational excellence. We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular, and chronic diseases across various phases to improve the health of millions worldwide.
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