Senior Clinical Trial Coordinator

KG Talent; Sydney; On-site; AUD 110,000 - 150,000; Full time

Job summary

Key Health Medical Centre in Sydney CBD South is seeking a Senior Clinical Trial Coordinator to lead the daily coordination and delivery of multiple clinical trials. You will work with Principal Investigators, researchers and sponsors to ensure studies meet protocol, GCP and regulatory standards.

You’ll mentor junior team members, oversee documentation and ensure audit readiness while driving participant recruitment and study timelines to successful completion.

Qualifications

• Experience coordinating clinical trials in a medical centre, hospital or CRO environment.
• Strong understanding of ICH-GCP and regulatory requirements.
• Experience with trial documentation and regulatory submissions.
• Proven ability to manage multiple studies and stakeholders.
• Effective communication with investigators, nurses and sponsors.

Responsibilities

• Coordinate day-to-day activities across multiple clinical trials and lead start-up activities.
• Maintain TMF/eTMF and study documentation to ensure audit readiness.
• Support ethics submissions, amendments and safety reporting.
• Manage participant recruitment, scheduling and retention in line with protocol timelines.
• Build strong relationships with sponsors, CROs, CRAs and study teams.

Skills

Clinical trial coordination

Stakeholder management

GCP knowledge

Attention to detail

Communication

Education

Bachelor of Nursing

Tools

EDC

CTMS

eTMF

Job description

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 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

Team Support & Leadership

• 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 collaborative team environment
• Modern Sydney CBD South location
• Ongoing learning and professional 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.