Overview
Clinical Trials Coordinator (with scope to progress to Clinical Trial Manager)
Company: Integra Trials Pty Ltd, a Perth‐based clinical trials company
Location: Nedlands, Perth, Western AustraliaEmployment Type: 0.4-1.0 FTE (flexible hours may be required)Reports to: Director / Principal InvestigatorKey Stakeholders: Investigators, clinical sites, HRECs, sponsors, CROs, overseas pharmaceutical partners, memory clinic clinicians, and community partners
The Clinical Trials Coordinator will play a central role in the establishment and delivery of clinical trials conducted by Integra Trials, a newly formed, Perth-based clinical trials company.
The role will support the end-to-end coordination of investigator-initiated and industry-sponsored clinical trials, with a strong focus on trials involving cognitive disorders, including Alzheimer's disease and other neurodegenerative conditions. The position will ensure compliance with Australian and international regulatory requirements, Good Clinical Practice (GCP), and ethical standards.
The role will suit a motivated clinical research professional with strong organisational capability and developing leadership skills, who is comfortable working in a start-up environment, working closely with patients and caregivers, and liaising with local and international stakeholders, including overseas pharmaceutical companies.
Key Responsibilities and Accountabilities
Dependent on project requirements, responsibilities may include:
* Clinical Trial Coordination and Conduct
o Coordinate participant recruitment, screening, data collection, and study-related activities in accordance with approved study protocols.
o Ensure clinical trials are conducted in compliance with the National Statement on Ethical Conduct in Human Research, ICH-GCP guidelines, study-specific protocols, and all applicable Australian and international laws and regulations.
o Coordinate trial procedures, participant visits, and study-related assessments.
o Provide education to participants and where appropriate, caregivers or family members, regarding study procedures, medication regimens, appointment schedules, and compliance requirements.
o Support coordination of cognitive assessments, diagnostic procedures, and follow-up visits in collaboration with memory clinic clinicians and research staff.
Start-up, Ethics and Regulatory Activities
* Support and contribute to trial start-up activities including preparation and review of investigator brochures, participant information and consent forms, study budgets, timelines, and safety reporting plans.
* Prepare, submit, and coordinate ethics and governance applications and amendments in accordance with Human Research Ethics Committee (HREC) and site governance requirements.
* Assist with site initiation, training, delegation logs, and trial documentation.
* Contribute to the establishment of systems, processes, and workflows to support efficient trial and memory clinic operations, particularly in a start-up environment.
Data, Safety and Quality Oversight
* Ensure accurate and timely data collection, data entry, and source documentation.
* Identify, document, and escalate risks, protocol deviations, and issues associated with trial conduct, ethics, safety reporting, or data integrity.
* Support monitoring activities, audits, and inspections as required.
* Participate in quality improvement activities, audits, and review of processes to improve participant experience, data quality, and protocol adherence.
Stakeholder and Sponsor Liaison
* Communicate and liaise professionally with investigators, memory clinic clinicians, and hospital and clinic staff (medical, nursing, allied health, pathology, pharmacy, and administrative teams) to support integrated clinical and research activities.
* Coordinate interdisciplinary collaboration, including referrals and consultations with geriatricians, neuropsychologists, allied health professionals, and other specialists as required.
* Coordinate meetings and teleconferences with internal and external stakeholders.
* Act as a key point of contact for sponsors, CROs, and overseas pharmaceutical partners, ensuring timely communication, reporting and issue resolution.
Patient, Caregiver and Community Engagement
* Support outreach and engagement activities in collaboration with internal teams and community partners to promote awareness of cognitive research and early intervention opportunities.
Team and Operational Support (Desirable / Developing)
* Assist in coordinating the clinical trials team to ensure effective use of time and resources.
* Contribute to the development and maintenance of standard operating procedures (SOPs) and trial workflows.
* Support mentoring or supervision of junior staff as the company grows.
* Undertake other duties reasonably expected within the scope of the role.
Selection Criteria
Essential Qualifications
* Completion of a relevant degree (e.g. health sciences, nursing, allied health, biomedical science) with subsequent relevant experience, or an equivalent combination of education, training, and experience.
Essential Knowledge, Experience and Skills
* Demonstrated experience in clinical trials or clinical research, including interaction with pharmaceuticals, investigators, and healthcare professionals.
* Sound understanding of clinical trial conduct, documentation, and regulatory requirements.
* Strong organisational and time management skills, with the ability to prioritise tasks and meet deadlines in a dynamic environment.
* Demonstrated ability to solve problems, exercise judgement, and work with a high level of discretion.
* Excellent written and verbal communication skills, with the ability to liaise effectively with a diverse range of stakeholders, including those from different cultural and international backgrounds and individuals navigating complex or emotionally challenging circumstances.
* High level of computer literacy, including databases, word processing, spreadsheets, and electronic health or clinical record systems.
* Strong attention to detail, numeracy, and data validation skills, with a methodical and protocol-driven approach.
* Ability to work independently and collaboratively as part of a multidisciplinary team.
* Demonstrated leadership or managerial experience, or clear potential to progress into a clinical trial management role.
* Clinical or research experience in neurological conditions, cognitive disorders, dementia, or related medical research, or an aligned allied health discipline.
* Experience working in aged care, geriatrics, memory clinics, or services supporting individuals with neurodegenerative conditions.
* Knowledge of dementia-related disorders, cognitive assessments, and community support resources for memory care.
* Thorough understanding of human research ethics and ICH-GCP guidelines.
* Experience working with industry-sponsored trials or international pharmaceutical companies.
* Experience contributing to SOP development, trial budgets, or operational planning.
Work Requirements
* Criminal record check in accordance with relevant assessment procedures.
* A level of physical fitness commensurate with the position.
* Capacity to work outside normal office hours when required, including meetings with overseas stakeholders across time zones.
About Integra Trials
Integra Trials is a Perth-based clinical trials unit specialising in Phase II/III clinical trials in neurological and cognitive disorders, including Alzheimer's disease. We work closely with clinicians, academic researchers, and international pharmaceutical partners to deliver high-quality clinical trials and accelerate the development of new therapies for neurodegenerative diseases.
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