Study Coordinator

About 360biolabs

360biolabs, a BioAgilytix company based in Melbourne, Victoria, is Australia's leading accredited specialty laboratory service provider. Integrated within a prominent global contract research organisation, 360biolabs supports the development of groundbreaking medicines through rigorous pharmacokinetic (PK) and pharmacodynamic (PD) assay development and execution across multiple therapeutic fields, facilitating client clinical trials and preclinical studies.

As a member of 360biolabs, employees work with top-tier professionals and advanced technologies in the domain, benefiting from numerous growth opportunities locally and globally. The company prioritises employee wellbeing and engagement through extensive wellness and community programs, reflecting the value placed on its people.

Role Overview

The Study Coordinator position involves assisting with coordination of clinical projects supervised by 360biolabs. Duties include preparing clinical study documentation and supporting the execution of collaborative research and development activities in compliance with NATA R&D and standard operating procedures (SOPs).

Core Responsibilities

• Support planning and initiation efforts required to launch new clinical studies.
• Compose and evaluate clinical study laboratory manuals, analytical protocols, and associated reports.
• Collaborate and communicate with internal teams, partner entities, and client representatives to align project objectives and activities.
• Deliver coordination support for clinical project teams throughout study progression.
• Engage in clinical project and team discussions to track progress and facilitate reporting.
• Participate in company meetings pertinent to project and client management functions.
• Compile and review documentation reflecting clinical activities, timelines, and results.
• Maintain recordkeeping consistent with applicable regulatory and quality standards.
• Assist in generating internal and client-facing reports.
• Follow institutional quality standards and regulatory requirements including ISO/IEC 17025, OECD GLP principles, GCLP standards, and NATA Accreditation protocols.
• Foster effective communication and maintain professional relationships with colleagues, clients, CROs, collaborators, and partners.
• Support personal development by attending relevant clinical research meetings, training sessions, and seminars as needed.

Candidate Profile and Selection Criteria

• Possess a Bachelor of Science with Honours or an equivalent qualification accompanied by relevant work experience.
• Demonstrated expertise in medical laboratory techniques is mandatory.
• Strong organisational abilities coupled with proficient writing skills are essential.
• Ability to collaborate effectively within team environments.
• Excellent communication capabilities.
• Competency in Microsoft Office suite, including Word, Excel, and PowerPoint.
• Experience working with database software and managing file systems.
• Previous involvement in clinical trial conduct is advantageous.
• A high level of enthusiasm and motivation for advancing medical research and pharmaceutical development is desirable.

Additional Information

Applicants must be residents of Australia or New Zealand with valid Australian work rights. 360biolabs promotes a diverse and inclusive workplace, welcoming applications from Aboriginal and Torres Strait Islander Peoples, LGBTQIA+ community members, and individuals with disabilities. The company encourages submission of a CV and cover letter demonstrating suitability for the role.

Please note, artificial intelligence tools may be employed during recruitment processes to assist with application review and assessment; however, final decisions rest with human recruiters.