26 Sep
|
Kanji Group
|
New South Wales
26 Sep
Kanji Group
New South Wales
Senior Clinical Trial Coordinator | Key Health
Help Advance Medical Research That Makes a Difference
Key Health Medical Centre is seeking an experienced and highly organised Senior Clinical Trial Coordinator to join our growing Clinical Research Unit (CRU) based in Sydney CBD South.
This is an exciting opportunity for an experienced clinical research professional to take a senior role in the coordination and delivery of high-quality clinical trials.
Working alongside experienced Research Nurses, Principal Investigators, Investigator GPs, sponsors and Contract Research Organisations (CROs), you'll play an important role in ensuring studies are delivered safely, efficiently and in accordance with protocol, Good Clinical Practice (GCP) and regulatory requirements.
If you have strong clinical research experience, excellent attention to detail and enjoy taking ownership of multiple studies, we'd love to hear from you.
About the Role
Reporting to the Clinical Trial Manager, you'll take responsibility for the day-to-day coordination and delivery of multiple clinical trials across the Clinical Research Unit.
You'll work closely with Principal Investigators, Research Nurses, sponsors and CROs, supporting studies from start-up through to close-out.
As a senior member of the team, you'll also provide guidance and support to other members of the clinical research team and help maintain high standards across study delivery, documentation and compliance.
Key Responsibilities
Study Coordination
Coordinate and take ownership of day-to-day activities across multiple clinical trials
Support and lead study start-up activities, including site initiation, feasibility activities and essential documentation
Coordinate study timelines, milestones and site activities to ensure protocols are delivered within required timeframes
Schedule participant visits and coordinate investigator and research nurse availability
Maintain accurate, complete and audit-ready Trial Master Files (TMF/eTMF) and study documentation
Support monitoring visits, audits and regulatory inspections
Identify, manage and elevate study issues, risks and protocol deviations as required
Support study close-out activities and ensure all documentation is completed appropriately
Participant Coordination
Support and coordinate participant recruitment, screening, enrolment and retention activities
Coordinate participant appointments in accordance with study protocols and required timeframes
Monitor participant progress, eligibility and retention throughout each study
Work closely with Research Nurses and investigators to ensure a positive participant experience
Ensure participant information and study documentation is maintained accurately and securely
Regulatory & Compliance
Coordinate and support ethics submissions, amendments, continuing reviews and safety reporting
Maintain regulatory files, delegation logs, training records and other essential documents
Ensure study documentation is complete, accurate and inspection-ready
Enter and maintain accurate study data within Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS)
Ensure studies are conducted in accordance with ICH-GCP, TGA, HREC and sponsor requirements
Identify compliance issues and work with the Clinical Trial Manager and investigators to address them
Sponsor & Stakeholder Management
Build robust working relationships with sponsors, CROs, Clinical Research Associates (CRAs) and study teams
Act as a key point of contact for day-to-day study coordination and site queries
Respond to data queries and study requests within required timeframes
Work closely with Principal Investigators, GPs, Research Nurses and the Clinical Trial Manager
Support study meetings and provide updates on recruitment, timelines, issues and study progress
Assist with study administration, invoicing, ordering study supplies and maintaining accountability logs
Provide guidance and support to Clinical Trial Coordinators, Research Nurses and other members of the research team where required
Share knowledge and support consistent clinical research processes across the CRU
Assist with onboarding and training new team members
Contribute to improving systems, processes and documentation within the Clinical Research Unit
About You
You'll be an experienced clinical research professional who is confident coordinating multiple studies and working with a range of internal and external stakeholders.
You'll have strong attention to detail, excellent organisational skills and the ability to take ownership of your responsibilities.
To be successful, you'll have:
Previous experience as a Clinical Trial Coordinator, Senior Clinical Trial Coordinator, Clinical Research Coordinator, Research Nurse or similar role
Experience coordinating clinical trials within a medical centre, research site, hospital, CRO or similar environment
Bachelor of Nursing preferred but candidates with other relevant science degrees will be considered
Strong understanding of ICH-GCP and clinical trial requirements
Experience working with clinical trial protocols, essential documents and regulatory requirements
Experience with EDC, CTMS and/or eTMF systems
Experience working with sponsors, CROs and CRAs
Understanding of HREC and TGA requirements
Strong organisational and time management skills, with the ability to manage multiple studies and competing priorities
Excellent communication and stakeholder management skills
High level of attention to detail and documentation accuracy
Confidence working independently and taking ownership of study activities
A proactive approach to identifying and resolving issues
Current GCP Certification will be highly regarded
Why Join Key Health?
Be part of a growing Clinical Research Unit delivering meaningful medical research
Take ownership of a diverse range of clinical trials
Work alongside experienced clinicians, investigators and research professionals
Opportunity to develop your clinical research career in a senior capacity
Supportive and team-oriented team environment
Modern Sydney CBD South location
Ongoing learning and career development opportunities
If you're an experienced clinical research professional looking for your next step and want to play a key role in delivering clinical trials that can improve patient outcomes, we'd love to hear from you.
Key Health is an equal opportunity employer and welcomes applications from people of all backgrounds,experiencesand identities.
Prospective candidates willbe requiredto provide proof of legal work rights and may berequiredto undertake relevant, role-appropriate pre-employment screening.
If you require any reasonable adjustments toparticipatein the recruitment process at any stage, please let us know.
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📌 Senior Clinical Trial Coordinator (New South Wales)
🏢 Kanji Group
📍 New South Wales