Clinical Research Associate

Accelagen Pty Ltd; City of Melbourne; Presencial; AUD 90 000 - 120 000; Tempo integral

Resumo da oferta

Accelagen Pty Ltd is seeking a skilled CRA II/CRA III/Senior CRA to join our clinical operations team. The role involves managing and monitoring clinical trial sites from start-up to close-out across Australia and New Zealand, ensuring data integrity and compliance with ICH-GCP.

You will conduct site visits, manage SAE reporting, assist with regulatory submissions, and collaborate with project teams to drive quality trials. Travel interstate is required; a valid driver’s license is essential.

Qualificações

• Degree in Life Sciences, Pharmacy, Nursing, or related technical qualification.
• Minimum 3 years’ experience on independent on-site monitoring and site management.
• Advanced site monitoring skills from Phase 1 to Phase 4.
• Excellent knowledge of ICH-GCP and SAE regulatory reporting.
• Willingness to travel interstate across Australia for site visits.
• Ability to lead within a project team and work in a matrix environment.
• Valid Driver’s License is required.

Responsabilidades

• Perform site selection, initiation, monitoring and close-out visits and coordinate with sites to recruit participants.
• Provide monitoring visits and site management across protocols, sites and therapeutic areas.
• Manage SAE reporting, narratives and follow-up activities.
• Track regulatory submissions, approvals, recruitment and CRF completion with data query resolution.
• Assist with site setup including HREC/RGO governance submission and essential document collection.
• Coordinate study budgets negotiations and approvals; maintain regular communication with study teams.
• Prepare key study documents including study plans, manuals and PICFs; support preparation of study protocols.
• Assist in creating Pre-Study Visit and Site Initiation Visit materials with the Project Manager.
• Opportunity to manage projects and study proposals under mentorship.

Conhecimentos

Communication

Self-management

Detail orientation

Problem solving

Time management

Formação académica

Life Sciences/Pharmacy/Nursing degree

Descrição da oferta de emprego

We are a leading, locally positioned and globally adept Clinical Research Organisation (CRO) headquartered in Australia working with innovative clients across the globe to make a tangible impact on the future of human health and wellness. With over a decade of delivered success, our experience is widely varied across the health, wellness and disease spectrum. We offer end-to-end services across Strategic Consultants, Clinical Trials, Regulatory Affairs & Biometrics.

About the Role

We are looking for a dedicated and experienced CRA II/CRA III/Senior Clinical Research Associate (SCRA) to join our dynamic team across Australia and New Zealand. As a CRAII/CRAII/SCRA, you will play a crucial role in the management and monitoring of clinical trial sites, ensuring the smooth operation of clinical studies from start-up through to close-out. You will work across a variety of protocols, sites, and therapeutic areas, ensuring the integrity and quality of clinical research data.

Key Responsibilities

Clinical Trial Monitoring and Oversight

• Perform site selection, initiation, monitoring and close-out visits and work with sites to adapt, drive and track subject recruitment plans.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

Data Integrity and Participant Safety

• Manage the process of Serious Adverse Event (SAE) from reporting to resolution.
• Assist in the reporting, process production of reports, narratives and follow up of SAEs.

Regulatory and Compliance

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form
• (CRF) completion and submission, and data query generation and resolution.
• Support with site set up, including assistance in preparation of HREC and RGO and governance submission, preparation of regulatory doc packages, and essential document collection and management.

Site Support

• Administer protocol and study related training to assigned sites and establish regular lines of communication.
• Provide support in study budgets negotiations with potential investigators and approval of CTRA.

Communication and Co-ordination

• Collaborate and liaise with study team members for project execution support as appropriate.
• Prepare and assist in the preparation of key study documents including study plans, manuals and PICFs.
• Assist in the review and preparation of Clinical Study protocols.
• Support the creation of Pre-Study Visit and/or Site Initiation Visit presentation materials in collaboration with the Project Manager.
• Opportunity to manage projects and develop study proposals under the mentorship of the Project Manager.
• Opportunity to manage study budgets under the mentorship of the Project Manager.

Key Skills & Attributes

• Strong verbal and written communication skills, with the ability to present information clearly and effectively.
• Ability to work independently, self-manage, and proactively identify and resolve issues.
• Detail-oriented with a solid understanding of clinical trial procedures and regulatory guidelines.
• Strong problem-solving skills and ability to manage complex issues.
• Effective time management and organisational skills.

Qualifications & Experience

• Degree in Life Sciences, Pharmacy, Nursing, or a related technical qualification.
• Minimum 3 years’ experience on independent on-site monitoring and site management experience
• Advanced site monitoring skills ranging from Phase 1 to phase 4
• Excellent knowledge of ICH-GCP and SAE and regulatory reporting
• Available to travel interstate across Australia to attend study site visits
• Ability to work and display leadership within a project team
• Works efficiently and effectively in a matrix environment
• Valid Driver’s License is required.

Why Join Us?

At Accelagen, we pride ourselves on creating an inclusive and supportive work environment. As a CRAII/CRAIII/Senior CRA, you will be given the opportunity to grow and develop in the field of clinical research. If you’re passionate about advancing clinical trials and have the desire to contribute to impactful Clinical research, this is the perfect opportunity for you!

Accelagen is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.