Experienced Clinical Trials Coordinator

Sydney Clinical Trials Pty Ltd; Campbelltown; Presencial; AUD 70 000 - 90 000; Tempo parcial

Resumo da oferta

Sydney Clinical Trials Pty Ltd is seeking an experienced Clinical Trials Coordinator for a casual role up to 40 hours per week at Campbelltown NSW. The successful candidate will coordinate trials from start-up to close-out, ensuring adherence to GCP, ICH guidelines, and study protocols, while maintaining high-quality data and participant care.

Responsibilities include participant recruitment, data entry into EDC/CTMS, and assisting with audits.

Qualificações

• 2+ years coordinating sponsor-initiated pharma clinical trials in healthcare settings.
• Strong knowledge of ICH-GCP guidelines, trial regulations and ethics requirements.
• Experience across Phase I–IV trials; gastroenterology/hepatic areas beneficial.

Responsabilidades

• Coordinate all aspects of clinical trial activities from start-up through close-out.
• Manage participant recruitment, screening, follow-up visits, bookings, sample processing and shipment.
• Ensure compliance with study protocols, GCP and ICH guidelines.
• Prepare and maintain accurate trial documentation, source documents, and investigator site files.
• Enter study data into EDC systems and CTMS; track adverse events and report per protocol.
• Coordinate investigational product accountability and study-related supplies.
• Support audit and inspection readiness activities.
• Maintain confidentiality and safeguard participant data at all times.

Conhecimentos

Participant care

Organisational skills

Communication skills

Problem-solving

Attention to detail

Time management

Multitasking

Collaboration

Independence

Formação académica

Health Science / Life Science / Nursing degree

Ferramentas

CTMS

EDC systems

Descrição da oferta de emprego

Sydney Clinical Trials Pty Ltd – Campbelltown NSW

We are seeking an experienced and highly organised Clinical Trials Coordinator to join our growing clinical research team at Sydney Clinical Trials. In this role, you will be responsible for coordinating and managing clinical trials in accordance with Good Clinical Practice (GCP), study protocols, regulatory requirements, and organisational policies. The successful candidate will work closely with study investigators, sponsors, monitors, other clinical trial coordinators and research participants to ensure the successful delivery of high-quality clinical research studies. This role is a casual role up to 40 hours per week with the potential to progress to a permanent role.

Key responsibilities

• Coordinate all aspects of clinical trial activities from study start-up through to close-out.
• Manage participant recruitment, screening, follow-up visits, participant appointment bookings, laboratory sample processing and shipment.
• Ensure compliance with study protocols, GCP and ICH guidelines
• Prepare and maintain accurate trial documentation, source documents, and investigator site files.
• Collect, review, and enter study data into electronic data capture systems and CTMS.
• Track adverse events and ensure timely reporting in accordance with protocol and regulatory requirements.
• Coordinate investigational product accountability and study-related supplies.
• Support audit and inspection readiness activities.
• Maintain confidentiality and safeguard participant data at all times.

About you

• Minimum of 2 years' experience coordinating Sponsor initiated pharmaceutical clinical trials in a research, hospital, or healthcare setting
• Excellent participant care and participant facing soft skills
• Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and ethics requirements
• Experience managing multiple studies simultaneously
• Excellent organisational, communication, and problem-solving skills
• High attention to detail and ability to meet deadlines
• Capability in prioritising workload and multitasking
• GCP R3 certification
• Ability to collaborate in a healthcare team and work independently
• A degree in Health Science, Life Science, Nursing, or a related discipline
• Experience across Phase I-IV clinical trials
• IATA certification
• Experience in gastroenterology and hepatic therapeutic areas
• Previous experience working with Sponsors and CROs

About us

• Sydney Clinical Trials is a niche growing clinical research team based inside Campbelltown Private Hospital. We specialise in gastroenterology and cardiometabolic trials.
• Competitive salary, negotiable depending on skills and experience
• Supportive, friendly and collaborative research environment
• Close to public transport
• Opportunity to contribute to innovative clinical research that improves patient outcomes