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About the Role

This role involves the day-to-day coordination and delivery of multiple clinical trials within the Clinical Research Unit, supporting studies from start-up to close-out. As a senior team member, you will provide guidance to other clinical research staff and help maintain high standards in study delivery, documentation, and compliance.

Responsibilities

Coordinate and take ownership of day-to-day activities across multiple clinical trials.
Support and lead study start-up activities, including site initiation, feasibility, 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 escalate study issues, risks, and protocol deviations.
Support study close-out activities and ensure all documentation is completed appropriately.
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.
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.
Build strong 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 research team members.
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.

Requirements

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.
Strong understanding of ICH-GCP and clinical trial requirements.
Experience working with clinical trial protocols, essential documents, and regulatory requirements.
Experience working with sponsors, CROs, and CRAs.
Understanding of HREC and TGA requirements.
Strong organizational 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.
Prospective candidates will be required to provide proof of legal work rights.
May be required to undertake relevant, role-appropriate pre-employment screening.
If you require any reasonable adjustments to participate in the recruitment process at any stage, please let us know.

Skills

Clinical trial coordination
Study start-up
Site initiation
Feasibility activities
Essential documentation management
Timeline management
Participant scheduling
Trial Master File (TMF/eTMF) maintenance
Monitoring visit support
Audit support
Regulatory inspection support
Issue and risk management
Protocol deviation management
Study close-out activities
Participant recruitment
Participant screening
Participant enrolment
Participant retention
Participant appointment coordination
Participant monitoring
Ethics submissions
Safety reporting
Regulatory file maintenance
Delegation log maintenance
Training record maintenance
Electronic Data Capture (EDC) systems
Clinical Trial Management Systems (CTMS)
ICH-GCP compliance
TGA requirements
HREC requirements
Sponsor requirements
Stakeholder management
Data query resolution
Study administration
Invoicing
Study supply ordering
Accountability log maintenance
Team guidance and support
Knowledge sharing
Process improvement
Onboarding and training support

Location

Sydney CBD South

Work Type

Full-time

Experience Level

Senior

Education Level

Bachelor of Nursing preferred
Other relevant science degrees will be considered

Benefits

Ongoing learning and professional development opportunities

About the Company

Key Health Medical Centre is seeking an experienced and highly organised Senior Clinical Trial Coordinator to join our growing Clinical Research Unit (CRU).
Be part of a growing Clinical Research Unit delivering meaningful medical research.
Work alongside experienced clinicians, investigators and research professionals.
Opportunity to develop your clinical research career in a senior capacity.
Supportive and collaborative team environment.
Modern Sydney CBD South location.

Equal Opportunity

Key Health is an equal opportunity employer and welcomes applications from people of all backgrounds, experiences and identities.