Clinical Research Associate

This is a fully remote position, open to applicants in Australia.

📋 Description

• Oversee the identification, feasibility evaluation, and selection of investigators and sites to carry out the trial.

• Execute all monitoring tasks according to the Monitoring Plan, including the timely and accurate completion of monitoring visit reports.

• Organize, prepare, and conduct site evaluation visits, providing reports on these visits to aid in site selection.

• Prepare, submit, and collaborate with regulatory specialists regarding the development of regulatory packages, importation/exportation requirements, and updates to Ethics Committee packages.

• Negotiate site budgets, facilitate site contract execution, monitor invoicing, and ensure prompt site payments.

• Plan, organize, and conduct site initiation visits.

• Create and maintain suitable monitoring tools and project-specific documentation.

• Inspire and train investigators to ensure that trial site personnel thoroughly understand the protocol, investigational product, and trial requirements to fulfill their responsibilities accurately and within deadlines.

• Gather, review, and authorize essential documents from trial sites to ensure quality and compliance, and code documents for the Trial Master File (TMF) filing.

• Reconcile the contents of the in-house TMF with the site’s Investigator Site Files.

• Manage the distribution, tracking, handling, and disposal of investigational products and other trial supplies as per site/trial requirements.

• Maintain trial information using the clinical trial management system and other tracking and reporting tools relevant to the trial.

• Assist in strategies aimed at enhancing recruitment efforts.

⛳️ Requirements

• Tertiary qualifications in a relevant science or healthcare field.

• Prior experience in clinical trials within an academic, CRO, or pharmaceutical setting, with 2-5 years of on-site monitoring and site management experience is essential.

• Experience in Oncology and/or early-phase clinical trials is an advantage.

• Proven knowledge of ICH-GCP guidelines and local and global ethical and regulatory research standards.

• Competence in key technical areas such as ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.

• Proficiency in business skills including negotiation and conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Strong interpersonal communication and presentation skills, along with the flexibility to work effectively within a multidisciplinary team and engage with a diverse range of stakeholders.

• Ability to be adaptable and flexible in response to changing organizational priorities and uncertain environments.

• Willingness and capability to travel.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Enjoy hybrid or remote work options based on your location and role.

• Career Growth: Access to numerous learning opportunities and a global network of scientific leaders to foster your growth and development in your role.

• Employee Wellbeing: Engage in programs and initiatives designed to enhance work-life balance, health, and team cohesion, including global engagement surveys, recognition programs, and team-building activities.

• Global Opportunities: Join a company with international reach, providing exposure to a variety of projects and clients.